FDA 510(k) Application Details - K053552

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K053552
Device Name	Media, Reproductive
Applicant	INTL., INC. 393 SOUNDVIEW RD. GUILFORD, CT 06437 US Other 510(k) Applications for this Company
Contact	MICHAEL D CECCHI Other 510(k) Applications for this Contact
Regulation Number	884.6180   More FDA Info for this Regulation Number
Classification Product Code	MQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2005
Decision Date	05/19/2006
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