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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 K983182
Device Name ALOE THERAPY ORAL RINSE
Applicant
Carrington Laboratories, Inc.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact E.J. Smith
Correspondent
Carrington Laboratories, Inc.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact E.J. Smith
Classification Product Code
OLR  
Date Received09/11/1998
Decision Date 12/10/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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