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510(k) K191955

Enhanced External Counter Pulsation Device Plus Omay-A by Omay(Guangzhou)Med Technologies Co., Ltd. — Product Code DRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2020
Date Received
July 22, 2019
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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