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510(k) K012141

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE by External Counterpulsation Lab — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2001
Date Received
July 10, 2001
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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