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510(k) K800907

TOMAC WET DRESSING WARMER by W.G. Whitney Corp. — Product Code KGX

K800907 is an FDA 510(k) premarket notification submitted by W.G. Whitney Corp. for the device "TOMAC WET DRESSING WARMER". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. W.G. Whitney Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1980
Date Received
April 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
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)
  • K781322 — STERILE WET DRESSING PACK (August 17, 1978)
  • K770387 — UNICATCH (April 5, 1977)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources