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FDA 510(k) Application Details - K991271
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K991271
Device Name
Needle, Assisted Reproduction
Applicant
CASMED UK
39 NORK WAY BANSTEAD
SURREY SM7 1PB GB
Other 510(k) Applications for this Company
Contact
DEBORAH CASTLE
Other 510(k) Applications for this Contact
Regulation Number
884.6100
More FDA Info for this Regulation Number
Classification Product Code
MQE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/13/1999
Decision Date
03/08/2000
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
FDA Source Information for K991271
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