510(k) K831615

DROP FOOT BRACE by Edward Dilauro, Jr. — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1983
Date Received
May 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type