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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 K141863
Device Name PURICORE WOUND HYDROGEL SPRAY DRESSING
Applicant
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Applicant Contact ART MORSE
Correspondent
Puricore, Inc.
508 Lapp Rd.
Malvern,  PA  19355
Correspondent Contact ART MORSE
Classification Product Code
FRO  
Date Received07/10/2014
Decision Date 05/14/2015
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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