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510(k) K102115

ODFS PACE by Odstock Medical, Ltd. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2011
Date Received
July 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

Other clearances by Odstock Medical, Ltd.

  • K171396 — ODFS Pace XL (January 31, 2018)

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