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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 K964852
Device Name RADIACARE ORAL WOUND RINSE
Applicant
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Applicant Contact DENNIS R SPARKMAN, PH.D.
Correspondent
Carrington Laboratories, Inc.
P.O. Box 168128
Irving,  TX  75061
Correspondent Contact DENNIS R SPARKMAN, PH.D.
Classification Product Code
OLR  
Date Received12/03/1996
Decision Date 03/03/1997
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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