FDA 510(k) Application Details - K110819

Device Classification Name	Culdoscope (And Accessories)   More FDA Info for this Device
510(K) Number	K110819
Device Name	Culdoscope (And Accessories)
Applicant	J.SINGH INSTRUMENTS 611 WEST 5TH STREET 3RD FLOOR AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	CAROLINE TONTINI Other 510(k) Applications for this Contact
Regulation Number	884.1640   More FDA Info for this Regulation Number
Classification Product Code	HEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2011
Decision Date	10/05/2011
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