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FDA 510(k) Application Details - K013835
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K013835
Device Name
Speculum, Vaginal, Nonmetal
Applicant
DYNASCEND CONSULTING INT'L LLC.
1144 CANTON ST., SUITE 103
ROSWELL, GA 30075 US
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Contact
ALAM AHMED
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/19/2001
Decision Date
01/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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