FDA 510(k) Application Details - K990045

Device Classification Name	Instrument, Manual, Specialized Obstetric-Gynecologic   More FDA Info for this Device
510(K) Number	K990045
Device Name	Instrument, Manual, Specialized Obstetric-Gynecologic
Applicant	POAMAX L.L.C. 17 ALPHUS ST. POGUOSON, VA 23662 US Other 510(k) Applications for this Company
Contact	MICHAEL J PALMER Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	KNA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/1999
Decision Date	05/24/1999
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