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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 K874478
Device Name DYNAFILM
Applicant
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Applicant Contact LALAGOS
Correspondent
Ferris Mfg. Corp.
16 W. 300 83rd St.
Burr Ridge,  IL  60527
Correspondent Contact LALAGOS
Regulation Number878.4020
Classification Product Code
NAD  
Date Received11/02/1987
Decision Date 01/14/1988
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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