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510(k) K050177

COLACTIVE COLLAGEN WOUND DRESSING by Covalontechnologies, Inc. — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2005
Date Received
January 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
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)
  • 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)

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  • K242100 — SurgiAid Collagen Wound Dressing (HA) (October 16, 2025)
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