FDA 510(k) Application Details - K974376

Device Classification Name	Manipulator, Plunger-Like Joint   More FDA Info for this Device
510(K) Number	K974376
Device Name	Manipulator, Plunger-Like Joint
Applicant	J-TECH MEDICAL, INC. PO BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E.J SMITH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/1997
Decision Date	02/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review