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510(k) K832213

GAUZE CONVERSION CLASS II STERILE by Winn Hirsch & Assoc. — Product Code EFQ

K832213 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "GAUZE CONVERSION CLASS II STERILE". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
July 12, 1983
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 Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K830511 — ZANLEX, ZAN-TEX & ZANDEX (March 17, 1983)
  • K812391 — NEUROSPONGES (November 24, 1981)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K800195 — COTTON UNDER CAST PADDING (February 11, 1980)
  • K761155 — CELLULOSE EYE STICK (December 16, 1976)
  • K760513 — ELECTRODE, TEMPORARY MYOCARDIAL (October 15, 1976)
  • K760365 — BLANKET, BURN (August 11, 1976)

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