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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K910716
Device Name MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
Applicant
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Applicant Contact ROBERT L CASARSA
Correspondent
Richard Wolf Medical Instruments Corp.
7046 Lyndon Ave.
Rosemont,  IL  60018
Correspondent Contact ROBERT L CASARSA
Regulation Number876.1500
Classification Product Code
FCX  
Date Received02/20/1991
Decision Date 04/16/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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