FDA 510(k) Application Details - K142204

Device Classification Name	Tenaculum, Uterine   More FDA Info for this Device
510(K) Number	K142204
Device Name	Tenaculum, Uterine
Applicant	Bioceptive Inc. New Orleans BioInnovation Center, 1441 Canal Street, Ste 228 New Orleans, LA 70112 US Other 510(k) Applications for this Company
Contact	Steward B. Davis, M.D. Other 510(k) Applications for this Contact
Regulation Number	884.4530   More FDA Info for this Regulation Number
Classification Product Code	HDC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2014
Decision Date	12/19/2014
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