510(k) K983818

MITEK FASTIN RC ANCHOR by Mitek Products — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1998
Date Received
October 29, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type