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510(k) K121819

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2012
Date Received
June 21, 2012
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)
  • K112549 — IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND S (May 4, 2012)
  • K043296 — COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING (June 6, 2005)
  • K050177 — COLACTIVE COLLAGEN WOUND DRESSING (April 27, 2005)

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