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510(k) K834532

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1984
Date Received
December 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by W.G. Whitney Corp.

  • 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)
  • K781322 — STERILE WET DRESSING PACK (August 17, 1978)
  • K770387 — UNICATCH (April 5, 1977)

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  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)