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FDA 510(k) Application Details - K043614
Device Classification Name
Extractor, Vacuum, Fetal
More FDA Info for this Device
510(K) Number
K043614
Device Name
Extractor, Vacuum, Fetal
Applicant
MEDEVCO, INC.
2300 MCDERMOTT RD.
#200-207
PLANO, TX 75025 US
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Contact
KRISTA OAKES
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
12/30/2004
Decision Date
04/14/2005
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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