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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 K941694
Device Name ISL QC 2000 LASER
Applicant
Intelligent Surgical Lasers, Inc.
4520 Executive Dr., #1
Plz. Level
San Diego,  CA  92121
Applicant Contact S. MICHAEL SHARP
Correspondent
Intelligent Surgical Lasers, Inc.
4520 Executive Dr., #1
Plz. Level
San Diego,  CA  92121
Correspondent Contact S. MICHAEL SHARP
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/06/1994
Decision Date 05/12/1994
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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