FDA 510(k) Application Details - K143068

Device Classification Name	Esthesiometer   More FDA Info for this Device
510(K) Number	K143068
Device Name	Esthesiometer
Applicant	Medical Monofilament Manufacturing 121 Camelot Drive Plymouth, MA 02360 US Other 510(k) Applications for this Company
Contact	Michelle Hardiman Other 510(k) Applications for this Contact
Regulation Number	882.1500   More FDA Info for this Regulation Number
Classification Product Code	GXB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2014
Decision Date	01/14/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review