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510(k) K112549

IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER by Covalontechnologies, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
September 1, 2011
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 Covalontechnologies, Inc.

  • K163556 — MediClear PreOp (September 14, 2017)
  • K150550 — SilverCoat Silicone Foley Catheter (November 24, 2015)
  • K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND (August 13, 2012)
  • K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING (June 6, 2005)
  • K050177 — COLACTIVE COLLAGEN WOUND DRESSING (April 27, 2005)

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