510(k) K974376

JTECH ADJUSTER REFLEX GUN by J-Tech Medical, Inc. — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1998
Date Received
November 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manipulator, Plunger-Like Joint
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type