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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 K894977
Device Name OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
Applicant
Trimedyne, Inc.
1311 Valencia Ave.
Tustin,  CA  92680
Applicant Contact MERRITT M GIRGIS
Correspondent
Trimedyne, Inc.
1311 Valencia Ave.
Tustin,  CA  92680
Correspondent Contact MERRITT M GIRGIS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/07/1989
Decision Date 10/10/1989
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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