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510(k) K083103

ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B by Acrymed, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2009
Date Received
October 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Acrymed, Inc.

  • K091354 — ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING (October 21, 2009)
  • 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)
  • K011994 — ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 (November 8, 2001)
  • 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)

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