FDA 510(k) Application Details - K170602

Device Classification Name	Media, Reproductive   More FDA Info for this Device
510(K) Number	K170602
Device Name	Media, Reproductive
Applicant	Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705 US Other 510(k) Applications for this Company
Contact	Jayme Yamaguchi-Owens 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	03/01/2017
Decision Date	06/07/2017
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