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FDA 510(k) Application Details - K214004
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K214004
Device Name
Needle, Hypodermic, Single Lumen
Applicant
CC Biotechnology Corporation
No. 68, Gongye 5th Rd., Annan Dist.
Tainan 709015 TW
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Contact
Edgar Yeh
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2021
Decision Date
12/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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