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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 And Burn, Hydrogel W/Drug And/Or Biologic
510(k) Number K041268
Device Name SILVERSITE OR CALGITROL
Applicant
Adri
232 Main St. Suite 11a
Park Forest,  IL  60466
Applicant Contact GEORGE H SCHERR, PH.D.
Correspondent
Adri
232 Main St. Suite 11a
Park Forest,  IL  60466
Correspondent Contact GEORGE H SCHERR, PH.D.
Classification Product Code
MGQ  
Subsequent Product Code
FRO  
Date Received05/12/2004
Decision Date 09/20/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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