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510(k) K841735

ACU-DERM TRANSPARENT INCISE DRAPE by Acme United Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1984
Date Received
April 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Acme United Corp.

  • K961323 — LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING (June 19, 1996)
  • K961452 — LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING (May 31, 1996)
  • K952565 — LYOFOAM EXTRA (November 14, 1995)
  • K895764 — MODIFIED LYOFOAM WOUND DRESSINGS (September 10, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K864084 — LYOFOAM C ODOR-ABSORBING DRESSING (November 21, 1986)
  • K860085 — LYOFOAM WOUND DRESSINGS (June 27, 1986)
  • K860818 — ONE TIME ENTERAL FEEDING BAG (May 15, 1986)
  • K861015 — ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS (April 22, 1986)
  • K842186 — ACU-DERM TRANSPARENT WOUND DRESSING (August 24, 1984)

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