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510(k) K022078

SOLA, COUNTER-PULSATION, MODEL SECP-S by Sola Medical Devices, LLC — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2003
Date Received
June 26, 2002
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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