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510(k) K800716

ORTHOTIC LEG GAIT CORRECTOR DEVICE by Ipos Luneburg — Product Code ITO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1980
Date Received
March 31, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Twister, Brace Setting
Device Class
Class I
Regulation Number
890.3410
Review Panel
PM
Submission Type

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