510(k) K812719

PROSANA BELT by Bandwagon, Inc. — Product Code IQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
September 25, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Lumbar
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type