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510(k) K041244

POLYGRAM NET BIOFEEDBACK APPLICATION by Medtronic Vascular — Product Code HCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2004
Date Received
May 11, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

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