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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 K141660
Device Name NAWALUTION SKIN AND WOUND CLEANSER
Applicant
Nawa Heilmittel GmbH
700 Thirteenth St., NW
Washington,  DC  20005
Applicant Contact ALLYSON B MULLEN
Correspondent
Nawa Heilmittel GmbH
700 Thirteenth St., NW
Washington,  DC  20005
Correspondent Contact ALLYSON B MULLEN
Classification Product Code
FRO  
Date Received06/20/2014
Decision Date 10/31/2014
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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