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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 K952636
Device Name MEDLITE LASER SYSTEM
Applicant
Continuum Biomedical, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact LAURIE A RIDENER
Correspondent
Continuum Biomedical, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact LAURIE A RIDENER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/08/1995
Decision Date 07/31/1995
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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