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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K860892
Device Name CLINAGEL (ABSORBENT GEL)
Applicant
Schering Chemicals, C/O Ellis Pharmaceuticals
913 State Rd.
Princeton,  NJ  08540
Applicant Contact LEVI ELLIS
Correspondent
Schering Chemicals, C/O Ellis Pharmaceuticals
913 State Rd.
Princeton,  NJ  08540
Correspondent Contact LEVI ELLIS
Classification Product Code
FRO  
Date Received03/10/1986
Decision Date 07/23/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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