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510(k) K813296

CONVERTORS STERILE DISP. LAP SPONGE II by American Convertors Div., American Pharmaseal — Product Code EFQ

K813296 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "CONVERTORS STERILE DISP. LAP SPONGE II". The FDA issued a decision of Substantially Equivalent on December 29, 1981. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
November 23, 1981
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 American Convertors Div., American Pharmaseal

  • K840957 — ANTIMICROBIAL INCISE DRAPE (June 7, 1984)
  • K832137 — CONVERTORS FLASH STERILIZING TRAY (August 12, 1983)
  • K830786 — DISIMETRIC RELEASE OF INSTRANETICS RAD (May 18, 1983)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)
  • K813419 — COMFORT CUSHION DRY BURN PAD III (January 22, 1982)
  • K813078 — CONTURA DISPOS. SURG. FACE MASK (December 18, 1981)
  • K812554 — TOMAC STERILE DISP. LAP SPONGE (September 24, 1981)
  • K802919 — ISO-BAC INSTRUMENT WRAP (February 2, 1981)
  • K802998 — PATIENT CARE DISPOSABLE INFANT SHIRTS (December 22, 1980)
  • K802359 — DISP. FENESTRATED SURG. DRAPE SHEETS (October 31, 1980)

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)

FDA data resources