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FDA 510(k) Application Details - K100916
Device Classification Name
Clamp, Circumcision
More FDA Info for this Device
510(K) Number
K100916
Device Name
Clamp, Circumcision
Applicant
MEDICON, E.G.
GANSACKER 15
TUTTLINGEN D-78532 DE
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Contact
JOACHIM SCHMID
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HFX
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More FDA Info for this Product Code
Date Received
04/02/2010
Decision Date
12/06/2010
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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