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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 K931606
Device Name 7-510-25 HYSTEROMED TUBING KIT
Applicant
NORTECH
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact KENNETH J SIKORA
Correspondent
NORTECH
3930 VENTURA DR.
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact KENNETH J SIKORA
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/01/1993
Decision Date 01/24/1994
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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