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FDA 510(k) Application Details - K082349
Device Classification Name
Tenaculum, Uterine
More FDA Info for this Device
510(K) Number
K082349
Device Name
Tenaculum, Uterine
Applicant
J. JAMNER SURGICAL INSTRUMENTS, INC.
589 DAVIES DRIVE
YORK, PA 17402 US
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Contact
JENNIFER BOSLEY
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HDC
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More FDA Info for this Product Code
Date Received
08/15/2008
Decision Date
11/21/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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