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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 K874648
Device Name COHERENT XA-30/SP CO2 SURGICAL LASER
Applicant
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Applicant Contact VIRGINIA SINGER
Correspondent
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Correspondent Contact VIRGINIA SINGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/13/1987
Decision Date 02/04/1988
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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