510(k) K933418

HAND THERAPY ASSOST by Bardon Ent., Inc. — Product Code JFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1994
Date Received
July 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Finger, Powered
Device Class
Class I
Regulation Number
890.5410
Review Panel
PM
Submission Type