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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 K992574
Device Name OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
Original Applicant
TRIMEDYNE, INC.
2801 barranca rd.
p.o. box 57001
irvine,  CA  92619 -7001
Original Contact susan h gamble
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/02/1999
Decision Date 10/29/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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