FDA 510(k) Application Details - K182675

Device Classification Name	Hysteroscope (And Accessories)   More FDA Info for this Device
510(K) Number	K182675
Device Name	Hysteroscope (And Accessories)
Applicant	Polygon Medical, Inc. 18 Hillside Drive Holliston, MA 01746 US Other 510(k) Applications for this Company
Contact	Ronald Adams 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	09/26/2018
Decision Date	01/04/2019
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