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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 K875338
Device Name CHRYS(TM) MODEL MED-MAX
Applicant
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact VICTOR C KEMP
Correspondent
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Correspondent Contact VICTOR C KEMP
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/30/1987
Decision Date 04/13/1988
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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