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510(k) K150550

SilverCoat Silicone Foley Catheter by Covalontechnologies, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2015
Date Received
March 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Covalontechnologies, Inc.

  • K163556 — MediClear PreOp (September 14, 2017)
  • 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)
  • K050177 — COLACTIVE COLLAGEN WOUND DRESSING (April 27, 2005)

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