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FDA 510(k) Application Details - K013460
Device Classification Name
Extractor, Vacuum, Fetal
More FDA Info for this Device
510(K) Number
K013460
Device Name
Extractor, Vacuum, Fetal
Applicant
SWIFT DELIVERY PRODUCTS
6824 ELK CANYON RD.
OKLAHOMA CITY, OK 73162 US
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Contact
RICHARD G LINDSAY
Other 510(k) Applications for this Contact
Regulation Number
884.4340
More FDA Info for this Regulation Number
Classification Product Code
HDB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2001
Decision Date
01/17/2002
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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