Home / 510(k) Clearances / K791888

510(k) K791888

CATHETER CARE KIT REORDER 7940&7941 by Ascep, Inc. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
September 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Ascep, Inc.

  • K830219 — VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (April 12, 1983)
  • K822893 — G.E.V. DISPOSABLE SCALPELS (October 22, 1982)
  • K810004 — STERILE DISPOSABLE INSTRUMENT TRAYS (January 26, 1981)
  • K802726 — INSTRUMENTS NONSTERILE & STERILE (November 19, 1980)
  • K791886 — I.V. CARE KIT (October 26, 1979)
  • K791885 — I.V. START SET (October 22, 1979)
  • K791889 — SUTURE REMOVAL TRAY, REORDER 7950&7951 (October 17, 1979)
  • K791887 — CENTRAL VENOUS CATHETER DRESSING TRAY (October 17, 1979)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)