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FDA 510(k) Application Details - K063429
Device Classification Name
Clamp, Circumcision
More FDA Info for this Device
510(K) Number
K063429
Device Name
Clamp, Circumcision
Applicant
GENERIC MEDICAL DEVICE, INC.
3906 ROSELAND ST.
HOUSTON, TX 77006 US
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Contact
MONICA MONTANEZ
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2006
Decision Date
01/17/2007
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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