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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 K904149
Device Name FLEXISYS
Applicant
Dornier Medtech America, Inc.
824 Livingston Ct.
Marietta,  GA  30067
Applicant Contact ROBERT E YOCHER
Correspondent
Dornier Medtech America, Inc.
824 Livingston Ct.
Marietta,  GA  30067
Correspondent Contact ROBERT E YOCHER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/07/1990
Decision Date 12/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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