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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 K953494
Device Name TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY
Original Applicant
TRIMEDYNE, INC.
2801 barranca rd.
irvine,  CA  92714 -5114
Original Contact susan h gamble
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/25/1995
Decision Date 09/14/1995
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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