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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 K962632
Device Name OMNIPULSE/OMNIPULSE-MAX
Applicant
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619
Applicant Contact SUSAN H GAMBLE
Correspondent
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619
Correspondent Contact SUSAN H GAMBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/05/1996
Decision Date 01/16/1997
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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