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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K870505
Device Name OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
Applicant
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact KIMBERLEY DONEY
Correspondent
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact KIMBERLEY DONEY
Regulation Number874.4500
Classification Product Code
LLO  
Date Received02/04/1987
Decision Date 08/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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