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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K932432
Device Name KRONNER REINFORCING STYLETTE
Applicant
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Applicant Contact EDWARD C VOLLMER
Correspondent
Unimar, Inc.
475 Danbury Rd.
Wilton,  CT  06897
Correspondent Contact EDWARD C VOLLMER
Regulation Number884.4530
Classification Product Code
LKF  
Date Received05/20/1993
Decision Date 04/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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