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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 K861583
Device Name CO2 LASER BRONCHOSCOPE SYSTEM
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact CHARLES P GILL
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact CHARLES P GILL
Regulation Number874.4500
Classification Product Code
LLO  
Date Received04/29/1986
Decision Date 05/21/1986
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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