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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K964136
Device Name HYSTERO CO2-PNEU 2221
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 Number884.1700
Classification Product Code
HIG  
Date Received10/15/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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