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510(k) K093324

EMPI CONTINUUM by Empi — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
October 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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  • K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM (June 18, 2002)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
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