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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 K100918
Device Name VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
Applicant
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Applicant Contact DENNIS MAHONEY
Correspondent
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Correspondent Contact DENNIS MAHONEY
Classification Product Code
FRO  
Date Received04/02/2010
Decision Date 08/09/2010
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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