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510(k) K842186

ACU-DERM TRANSPARENT WOUND DRESSING by Acme United Corp. — Product Code NAD

K842186 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "ACU-DERM TRANSPARENT WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Acme United Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1984
Date Received
June 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
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)
  • K842064 — ACU-DERM TRANSPARENT IV DRESSING (August 15, 1984)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources