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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 K897157
Device Name OPTILASE YAG MODEL 1000 ACV 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 Received12/26/1989
Decision Date 02/22/1990
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
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