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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 K852190
Device Name MODEL 451 CO2 SURGICAL LASER
Applicant
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Applicant Contact LEN GOLDFINE
Correspondent
Coherent Medical Group
3270 W. Bayshore Rd.
P .O. Box 10122
Palo Alto,  CA  94303
Correspondent Contact LEN GOLDFINE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/22/1985
Decision Date 08/23/1985
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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