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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 K092232
Device Name MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
Applicant
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Applicant Contact DENNIS J MAHONEY
Correspondent
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Correspondent Contact DENNIS J MAHONEY
Classification Product Code
FRO  
Date Received07/23/2009
Decision Date 08/19/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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