510(k) K822632

ELBOW PROSTHESIS by Hosmer Dorrance Corp. — Product Code IRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 31, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Elbow, External Limb Component, Powered
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type