FDA 510(k) Application Details - K180496

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K180496
Device Name	Hysteroscope (And Accessories)
Applicant	Covidien 60 Middletown Ave. North Haven, CT 06473 US Other 510(k) Applications for this Company
Contact	Gail Yaeker-Daunis Other 510(k) Applications for this Contact
Regulation Number	884.1690   More FDA Info for this Regulation Number
Classification Product Code	HIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2018
Decision Date	08/29/2018
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