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510(k) K003452

POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D by Ep Technologies, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2000
Date Received
November 7, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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