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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 K944204
Device Name LATERALASE, MODIFIED
Applicant
TRIMEDYNE, INC.
2801 BARRANCA RD.
P.O. BOX 57001
IRVINE,  CA  92619 -7001
Applicant Contact SUSAN GAMBLE
Correspondent
TRIMEDYNE, INC.
2801 BARRANCA RD.
P.O. BOX 57001
IRVINE,  CA  92619 -7001
Correspondent Contact SUSAN GAMBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/12/1994
Decision Date 11/28/1994
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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