510(k) K021238

FRYE ADJUSTING INSTRUMENT by Frye Health Systems — Product Code LXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
April 18, 2002
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