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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 K925124
Device Name TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST
Original Applicant
TRIMEDYNE, INC.
47201 lakeview blvd.
p.o. box 5120
fremont,  CA  94537
Original Contact paul s kramsky
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/13/1992
Decision Date 03/01/1994
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
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