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510(k) K931417

STERILE EQUIPMENT COVERS by Custom Medical Products, Ltd. — Product Code MMP

K931417 is an FDA 510(k) premarket notification submitted by Custom Medical Products, Ltd. for the device "STERILE EQUIPMENT COVERS". The FDA issued a decision of Substantially Equivalent on July 6, 1995. The device falls under product code MMP (Cover, Barrier, Protective), a Class II device regulated under 21 CFR 878.4370. Custom Medical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1995
Date Received
March 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Barrier, Protective
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Custom Medical Products, Ltd.

  • K994199 — VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCED (June 9, 2000)
  • K931456 — SURGICAL DRAPE AND GOWN TRAY (July 8, 1994)
  • K931418 — SURGICAL DRAPE (May 5, 1994)
  • K930815 — ABDOMINAL / THORACIC PATIENT DRAPE (May 5, 1994)
  • K931455 — HEAD SHEET (May 5, 1994)
  • K931844 — CUSTOM PROCEDURE MEDICAL TRAY OR KIT (January 25, 1994)
  • K926519 — SURGICAL GOWN (August 12, 1993)
  • K900848 — ENEMA KIT 'STRAIGHT' DESIGN (April 13, 1990)
  • K900847 — ENEMA KIT 'Y' DESIGN (April 13, 1990)
  • K895084 — APERTURE (October 27, 1989)

Other clearances for product code MMP

  • K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN (July 31, 2009)
  • K043234 — LIGHT DRAPE (May 25, 2005)
  • K041501 — GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS (November 30, 2004)
  • K040794 — INCUBATOR CAPE (June 10, 2004)
  • K032065 — MEDLINE BAND BAGS AND EQUIPMENT COVERS (September 22, 2003)
  • K023540 — SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 (February 4, 2003)
  • K014239 — MEDSURG EQUIPMENT COVERS (February 19, 2002)
  • K970885 — ULTRASOUND SYSTEMS DRAPE (September 22, 1997)
  • K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER (January 30, 1997)
  • K961699 — EQUIPMENT COVERS (August 23, 1996)

FDA data resources