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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 K093159
Device Name PR CREAM
Applicant
Prugen IP Holdings, Inc.
8711 E Pinnacle Peak Rd.
Suite C-201, Pmb 225
Scottsdale,  AZ  85255
Applicant Contact ROBERT L KNECHTEL
Correspondent
Prugen IP Holdings, Inc.
8711 E Pinnacle Peak Rd.
Suite C-201, Pmb 225
Scottsdale,  AZ  85255
Correspondent Contact ROBERT L KNECHTEL
Classification Product Code
FRO  
Date Received10/06/2009
Decision Date 06/24/2010
Decision Substantially Equivalent (SESE)
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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