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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tenaculum, uterine
510(k) Number K082349
Device Name JARIT HULKA UTERINE TENACULUM FORCEPS
Applicant
J. JAMNER SURGICAL INSTRUMENTS, INC.
589 DAVIES DRIVE
YORK,  PA  17402
Applicant Contact JENNIFER BOSLEY
Correspondent
J. JAMNER SURGICAL INSTRUMENTS, INC.
589 DAVIES DRIVE
YORK,  PA  17402
Correspondent Contact JENNIFER BOSLEY
Regulation Number884.4530
Classification Product Code
HDC  
Date Received08/15/2008
Decision Date 11/21/2008
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
Recalls CDRH Recalls
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