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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 K022655
Device Name TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
Original Applicant
TRIMEDYNE, INC.
15091 bake pkwy.
irvine,  CA  92618
Original Contact glenn d yeik
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/09/2002
Decision Date 11/07/2002
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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