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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 K822058
Device Name GELIPERM TRANSPARENT GEL-FILM DRESSING
Applicant
Hamel, Park, Mccabe & Saunders
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hamel, Park, Mccabe & Saunders
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
FRO  
Date Received07/13/1982
Decision Date 08/12/1983
Decision Substantially Equivalent (SESE)
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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