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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 K915117
Device Name MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
Original Applicant
TRIMEDYNE, INC.
2801 barranca rd.
irvine,  CA  92714 -5114
Original Contact paul s.kramsky
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/13/1991
Decision Date 04/02/1992
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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