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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K012126
Device Name THE SALICEPT ORAL PATCH
Applicant
Carrington Laboratories, Inc.
2001 Walnut Hill Ln.
Irving,  TX  75038
Applicant Contact KENNETH M YATES
Correspondent
Carrington Laboratories, Inc.
2001 Walnut Hill Ln.
Irving,  TX  75038
Correspondent Contact KENNETH M YATES
Classification Product Code
OLR  
Date Received07/06/2001
Decision Date 10/03/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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