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FDA 510(k) Application Details - K013703
Device Classification Name
Accessory, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K013703
Device Name
Accessory, Assisted Reproduction
Applicant
SANYO NORTH AMERICA CORP.
900 N. ARLINGTON HEIGHTS RD.
SUITE 310
TASCA, IL 60143-2844 US
Other 510(k) Applications for this Company
Contact
SACHI KATAOKA
Other 510(k) Applications for this Contact
Regulation Number
884.6120
More FDA Info for this Regulation Number
Classification Product Code
MQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2001
Decision Date
12/14/2001
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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