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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, Occlusive
510(k) Number K895654
Device Name SORBEX(TM) SOFT SPONGE
Applicant
Fountain Pharmaceuticals, Inc.
P.O. Box 51863
Knoxville,  TN  37950
Applicant Contact W FOUNTAIN
Correspondent
Fountain Pharmaceuticals, Inc.
P.O. Box 51863
Knoxville,  TN  37950
Correspondent Contact W FOUNTAIN
Regulation Number878.4020
Classification Product Code
NAD  
Date Received09/20/1989
Decision Date 02/20/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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