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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name insufflator, laparoscopic
510(k) Number K934884
Device Name MODEL 2231 CO2 INSUFFLATOR
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Applicant Contact ROBERT L CASARSA
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS,  IL  60061
Correspondent Contact ROBERT L CASARSA
Regulation Number884.1730
Classification Product Code
HIF  
Date Received10/12/1993
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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