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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K232842
Device Name Balloon Inflation System
Applicant
Ningbo Hicren Biotechnology Co., Ltd.
Bldg. 1 Block B #777 Binhai 4th Rd. Hangzhou Bay
New District
Ningbo,  CN 315336
Applicant Contact Qian Jia
Correspondent
Pureid Medical Technology Co., Ltd.
Guangzhou International Biology Island Luoxuan Blvd. Guanzho
Life Science Innovation Cntr, Bd.A 3301-3310 & 3316-3318
Guangzhou,  CN
Correspondent Contact Raymond Wu
Regulation Number888.3027
Classification Product Code
NDN  
Date Received09/14/2023
Decision Date 02/29/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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