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510(k) K820051

OBUS FORME ORTHOPEDIC BRACE, UPRIGHT by Obus Forme, Ltd. — Product Code IQE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 29, 1982
Date Received: January 8, 1982
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