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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 K851405
Device Name TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700
Applicant
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Applicant Contact HANY HUSSEIN
Correspondent
Trimedyne, Inc.
1815 E. Carnegie Ave.
Santa Ana,  CA  92705
Correspondent Contact HANY HUSSEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/09/1985
Decision Date 10/07/1985
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
Predetermined Change
Control Plan Authorized		 No
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