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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 K903154
Device Name CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER
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 Received07/18/1990
Decision Date 11/23/1990
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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