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510(k) K802911

A/K SOCKET by Orthomedics — Product Code ISS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
November 17, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Thigh Socket, External Component
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type

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