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510(k) K011994

ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 by Acrymed, Inc. — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2001
Date Received
June 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Acrymed, Inc.

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  • K082459 — ACRYDERM ABSORBENT OXYGEN DRESSING (September 19, 2008)
  • K070333 — ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL (July 10, 2007)
  • K061232 — ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (October 6, 2006)
  • K012116 — ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING (September 12, 2001)
  • K002909 — ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 (October 13, 2000)
  • K002599 — MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, (September 21, 2000)
  • K991818 — ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 10 (April 17, 2000)
  • K992032 — ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 (August 19, 1999)

Other clearances for product code MGQ

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  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)