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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Gastro-Urology Use
510(k) Number K861331
Device Name ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
Applicant
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact HUSSEIN, PH.D.
Correspondent
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact HUSSEIN, PH.D.
Regulation Number878.4810
Classification Product Code
LNK  
Date Received04/09/1986
Decision Date 08/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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