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510(k) K030587

EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP by S-Tct Health, Inc. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2003
Date Received
February 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Counter-Pulsating, External
Device Class
Class II
Regulation Number
870.5225
Review Panel
CV
Submission Type

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