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510(k) K914174

STERILE DISPOSABLE WET SKIN SCRUB TRAY by Medical Device Inspection Co., Inc. — Product Code LRO

K914174 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "STERILE DISPOSABLE WET SKIN SCRUB TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on February 24, 1992. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
February 24, 1992
Date Received
September 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Surgery Tray
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

Other clearances by Medical Device Inspection Co., Inc.

  • K945826 — J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFT (August 4, 1995)
  • K932072 — JARIT SURGICAL INSTRUMENTS (January 11, 1994)
  • K931594 — THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (December 21, 1993)
  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933581 — POWERMATIC TREATMENT TABLE (November 5, 1993)
  • K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)
  • K912075 — C-SECTION TRAY (April 7, 1992)
  • K920403 — XENON ARC ENDOSCOPE LIGHT SOURCE (February 21, 1992)

Other clearances for product code LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
  • K980137 — WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (January 30, 1998)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)

FDA data resources