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510(k) K950656

PED ALERT by Orbitec Technologies Corp. — Product Code IRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1995
Date Received
February 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Warning, Overload, External Limb, Powered
Device Class
Class II
Regulation Number
890.5575
Review Panel
PM
Submission Type

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