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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drainage catheter with antibiotic
510(k) Number K063245
Device Name ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
Applicant
BACTERIN INTERNATIONAL INC.
543 LONG HILL AVENUE
SHELTON,  CT  06484
Applicant Contact JOSEPH M AZARY
Correspondent
BACTERIN INTERNATIONAL INC.
543 LONG HILL AVENUE
SHELTON,  CT  06484
Correspondent Contact JOSEPH M AZARY
Regulation Number878.4780
Classification Product Code
OEI  
Date Received10/26/2006
Decision Date 11/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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