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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 K922497
Device Name OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM
Applicant
TRIMEDYNE, INC.
2801 BARRANCA RD.
IRVINE,  CA  92714 -5114
Applicant Contact PAUL S KRAMSKY
Correspondent
TRIMEDYNE, INC.
2801 BARRANCA RD.
IRVINE,  CA  92714 -5114
Correspondent Contact PAUL S KRAMSKY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/27/1992
Decision Date 03/01/1994
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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