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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 K082089
Device Name PRUMYX CREAM
Applicant
Prugen, Inc.
10 S. Lasalle St.
Suite 3300
Chicago,  IL  60603
Applicant Contact ROBERT L KNECHTEL
Correspondent
Prugen, Inc.
10 S. Lasalle St.
Suite 3300
Chicago,  IL  60603
Correspondent Contact ROBERT L KNECHTEL
Classification Product Code
FRO  
Date Received07/24/2008
Decision Date 01/13/2009
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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