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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 K113774
Device Name HPR PLUS EMOLLIENT FOAM
Applicant
Prugen IP Holdings, Inc.
8714 E. Vista
Bonita Dr.
Scottsdale,  AZ  85255
Applicant Contact SEAN LONERGAN
Correspondent
Prugen IP Holdings, Inc.
8714 E. Vista
Bonita Dr.
Scottsdale,  AZ  85255
Correspondent Contact SEAN LONERGAN
Classification Product Code
FRO  
Date Received12/22/2011
Decision Date 02/09/2012
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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