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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 K950996
Device Name DORNIER THERMAFOCUS 360 FIBER
Applicant
Daimler-Benz Aerospace
1155 Roberts Blvd.
Kennesaw,  GA  30144
Applicant Contact DEBORAH MOORE
Correspondent
Daimler-Benz Aerospace
1155 Roberts Blvd.
Kennesaw,  GA  30144
Correspondent Contact DEBORAH MOORE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/03/1995
Decision Date 10/03/1995
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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