FDA 510(k) Application Details - K970360

Device Classification Name	Passer   More FDA Info for this Device
510(K) Number	K970360
Device Name	Passer
Applicant	MITEK PRODUCTS 60 GLACIER DR. WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	EDWARD F KENT Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	HWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/1997
Decision Date	03/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review