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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 K013056
FOIA Releasable 510(k) K013056
Device Name GELCLAIR CONCENTRATED ORAL GEL
Applicant
SINCLAIR PHARMACEUTICALS, LTD.
1 ALDER BROOK
CHINLEY, HIGH PEAK,  GB SK23 6DN
Applicant Contact PRISCILLA COX
Correspondent
SINCLAIR PHARMACEUTICALS, LTD.
1 ALDER BROOK
CHINLEY, HIGH PEAK,  GB SK23 6DN
Correspondent Contact PRISCILLA COX
Classification Product Code
OLR  
Date Received09/11/2001
Decision Date 12/21/2001
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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