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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 K013974
Device Name RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
Applicant
Trimedyne, Inc.
15091 Bake Pkwy.
Irvine,  CA  92606
Applicant Contact SUSAN H GAMBLE
Correspondent
Trimedyne, Inc.
15091 Bake Pkwy.
Irvine,  CA  92606
Correspondent Contact SUSAN H GAMBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/03/2001
Decision Date 09/23/2002
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
Predetermined Change
Control Plan Authorized		 No
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