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FDA 510(k) Application Details - K132668
Device Classification Name
Speculum, Vaginal, Nonmetal
More FDA Info for this Device
510(K) Number
K132668
Device Name
Speculum, Vaginal, Nonmetal
Applicant
IOB MEDICAL INC
504E DIAMOND AVE.
SUITE F
GAITHERSBURG, MD 20877 US
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Contact
JOE XIA
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2013
Decision Date
01/17/2014
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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