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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 K933741
Device Name CARRASYN ORAL WOUND DRESSING
Applicant
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Applicant Contact A. WEIDENBACH
Correspondent
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Correspondent Contact A. WEIDENBACH
Classification Product Code
OLR  
Date Received08/03/1993
Decision Date 05/04/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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