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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K150752
Device Name GME ExSys 308
Applicant
Gme (German Medical Engineering) GmbH
Grimmstrasse 23
Nuerenberg, Bavaria,  DE 90491
Applicant Contact STEFAN SCHULZE
Correspondent
Philosopher'S River, LLC
P.O. Box 106
Willow Creek,  MT  59760
Correspondent Contact MIKE JOHNSON
Regulation Number878.4630
Classification Product Code
FTC  
Date Received03/23/2015
Decision Date 07/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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