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FDA 510(k) Application Details - K013497
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K013497
Device Name
Needle, Assisted Reproduction
Applicant
GYNETICS MEDICAL PRODUCTS NV
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact
GRACE HOLLAND
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
10/22/2001
Decision Date
11/09/2001
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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