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 Other 510(k) Applications for this Company
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