FDA 510(k) Application Details - K190414

Device Classification Name	More FDA Info for this Device
510(K) Number	K190414
Device Name	Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV
Applicant	Moss Tubes, Inc. 1929 Route 9 Castleton on Hudson, NY 12033 US Other 510(k) Applications for this Company
Contact	Michael Moss Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2019
Decision Date	06/14/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review