510(k) K983685

BONE BAND by Chapel and Assoc. — Product Code LYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1998
Date Received
October 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixation Accessory
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type