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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 K001676
Device Name OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
Applicant
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619 -7001
Applicant Contact SUSAN H GAMBLE
Correspondent
Trimedyne, Inc.
2801 Barranca Rd.
P.O. Box 57001
Irvine,  CA  92619 -7001
Correspondent Contact SUSAN H GAMBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/01/2000
Decision Date 11/02/2000
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
Predetermined Change
Control Plan Authorized		 No
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