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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 K913566
Device Name ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM
Applicant
Alfred O. Bonati, M.D.
7315 Hudson Ave.
Hudson,  FL  34667
Applicant Contact ALFRED O BONATI
Correspondent
Alfred O. Bonati, M.D.
7315 Hudson Ave.
Hudson,  FL  34667
Correspondent Contact ALFRED O BONATI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/09/1991
Decision Date 04/20/1993
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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