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FDA 510(k) Application Details - K032091
Device Classification Name
Clamp, Circumcision
More FDA Info for this Device
510(K) Number
K032091
Device Name
Clamp, Circumcision
Applicant
EMERGO GROUP, INC.
2454 MCMULLEN BOOTH ROAD
SUITE 427
CLERWATER, FL 33759 US
Other 510(k) Applications for this Company
Contact
RENE' VAN DE ZANDE
Other 510(k) Applications for this Contact
Regulation Number
884.4530
More FDA Info for this Regulation Number
Classification Product Code
HFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2003
Decision Date
03/08/2004
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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