FDA.report

510(k) K232842

Device
Balloon Inflation System
Applicant
Ningbo Hicren Biotechnology Co., Ltd.
510(k) number
K232842
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-29
Date received
2023-09-14
Regulation
888.3027
Classification name
Cement, Bone, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Qian Jia
Address
Bldg. 1 Block B #777 Binhai 4th Rd. Hangzhou Bay New District Ningbo CN 315336 315336

FDA Registration Numbers

Source Documents

510(k) summary PDF

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