FDA 510(k) Application Details - K141958

Device Classification Name	More FDA Info for this Device
510(K) Number	K141958
Device Name	ERB ENDORECTAL BALLOON
Applicant	EDGE MEDICAL LLC 3924 CASCADE BEACH RD. LUTSEN, MN 55612 US Other 510(k) Applications for this Company
Contact	GREGORY MATHISON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2014
Decision Date	11/18/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review