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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 K934486
Device Name COOL LASER OPTICS (CLO) UNIT
Applicant
Cyruschess
149 E. Ave.
Norwalk,  CT  06581
Applicant Contact CYRUS CHESS
Correspondent
Cyruschess
149 E. Ave.
Norwalk,  CT  06581
Correspondent Contact CYRUS CHESS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/13/1993
Decision Date 03/24/1994
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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