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510(k) K220920

Matreneu Percutaneous Balloon Compression Kit by Shenzhen Shineyard Medical Device Co. , Ltd. — Product Code HAO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2022
Date Received
March 30, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Non-Powered
Device Class
Class I
Regulation Number
882.4535
Review Panel
NE
Submission Type

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