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510(k) K232842

Balloon Inflation System by Ningbo Hicren Biotechnology Co., Ltd. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2024
Date Received
September 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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