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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K990906
Device Name FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
Applicant
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Applicant Contact THEODORE R THORSON
Correspondent
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Correspondent Contact THEODORE R THORSON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/18/1999
Decision Date 04/29/1999
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
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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