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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 K984539
Device Name FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
Applicant
FERRIS MFG. CORP.
16 WEST 300 83RD ST.
BURR RIDGE,  IL  60527
Applicant Contact THEODORE THORSEN
Correspondent
FERRIS MFG. CORP.
16 WEST 300 83RD ST.
BURR RIDGE,  IL  60527
Correspondent Contact THEODORE THORSEN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received12/21/1998
Decision Date 03/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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