510(k) K823152

OB HELP ARM by Orthion Corp. — Product Code ILE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1982
Date Received
October 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sling, Arm, Overhead Supported
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type