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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K192269
Device Name TwinScan 808/755 Laser System
Applicant
Gme German Medical Engineering GmbH
Grimmstrasse 23
Nuremberg,  DE 90491
Applicant Contact Stefan Schulze
Correspondent
Philosopher'S River, LLC
P.O. Box 106
Willow Creek,  MT  59760
Correspondent Contact Mike Johnson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/21/2019
Decision Date 11/19/2019
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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