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510(k) K932221

NEUROLOGICAL OR CRANI TRAYS (PACKS) by Associated Medical Products Co. — Product Code LRO

K932221 is an FDA 510(k) premarket notification submitted by Associated Medical Products Co. for the device "NEUROLOGICAL OR CRANI TRAYS (PACKS)". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Associated Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1997
Date Received
May 7, 1993
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 Associated Medical Products Co.

  • K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (April 19, 1994)
  • K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS) (February 22, 1994)
  • K932217 — MAJOR, MINOR, BASIN TRAYS (PACKS) (November 15, 1993)
  • K932220 — LAP CHOLY TRAYS (PACKS) (September 27, 1993)
  • K932218 — CARDIAC CATH OR ANGIOGRAPHIC TRAYS (August 27, 1993)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K842983 — AMPCO OPTHALMIC TRAY (May 22, 1985)
  • K843114 — AMPCO PROCEDURE TRAYS / PACKS (August 8, 1984)
  • K823839 — AMPCO KIDNEY DIALYSIS TRAY (March 29, 1983)
  • K821579 — SKIN SCRUB-TRAY (July 21, 1982)

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)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)

FDA data resources