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FDA 510(k) Application Details - K021193
Device Classification Name
Extractor, Vacuum, Fetal
More FDA Info for this Device
510(K) Number
K021193
Device Name
Extractor, Vacuum, Fetal
Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
12-9, LIN 5, MAO-CHANG VILLAGE
SAN-CHIH HSIANG
TAIPEI HSIEN 252 TW
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Contact
TAIPEI HSIEN
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
04/15/2002
Decision Date
02/12/2003
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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