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FDA 510(k) Application Details - K240806
Device Classification Name
Lancet, Blood
More FDA Info for this Device
510(K) Number
K240806
Device Name
Lancet, Blood
Applicant
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No. 278, Hangkong Road,
Tianjin Pilot Free Trade Zone (Air Port Industrial Park)
Tianjin 300308 CN
Other 510(k) Applications for this Company
Contact
Wang Ningning
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
FMK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/25/2024
Decision Date
05/21/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240806
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