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510(k) K781322

STERILE WET DRESSING PACK by W.G. Whitney Corp. — Product Code EFQ

K781322 is an FDA 510(k) premarket notification submitted by W.G. Whitney Corp. for the device "STERILE WET DRESSING PACK". The FDA issued a decision of Substantially Equivalent on August 17, 1978. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. W.G. Whitney Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1978
Date Received
July 31, 1978
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 W.G. Whitney Corp.

  • K834532 — STERILE WET DRESSING PACK (January 25, 1984)
  • K813535 — XEROFORM DRESSING (February 4, 1982)
  • K810406 — STERILE WET DRESSING PACK (March 11, 1981)
  • K803299 — COLD/HOT PACK (January 15, 1981)
  • K800907 — TOMAC WET DRESSING WARMER (May 20, 1980)
  • K770387 — UNICATCH (April 5, 1977)

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