FDA 510(k) Application Details - K172414

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K172414
Device Name	Condom
Applicant	Global Mailer Partners, LLC 50 South Pointe Drive Miami Beach, FL 33139 US Other 510(k) Applications for this Company
Contact	Jud Ireland Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/10/2017
Decision Date	10/12/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review