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510(k) K032954

ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 by Danmeter A/S — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2004
Date Received
September 22, 2003
Clearance Type
Abbreviated
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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