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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pipette, Sahli
510(k) Number K902263
Device Name OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
Applicant
Trimedyne, Inc.
1311 Valencia Ave.
Tustin,  CA  92680
Applicant Contact MERRITT M GIRGIS
Correspondent
Trimedyne, Inc.
1311 Valencia Ave.
Tustin,  CA  92680
Correspondent Contact MERRITT M GIRGIS
Regulation Number864.6160
Classification Product Code
GGX  
Date Received05/21/1990
Decision Date 07/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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