510(k) clearances

Filter Needle for Single Use

Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · General Hospital

K233277Substantially EquivalentTraditionalFPB
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
General Hospital
Address 1
104, 301, 302, Bldg. 12, Bldg. 1,619 Wangmei
Address 2
Rd.Inping St., Linping District
Statement or summary
Summary
Product code
FPB
Zip code
311199
Applicant
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Decision date
2024-05-10
Decision code
SESE
Country code
CN
Device name
Filter Needle for Single Use
Advisory committee
HO
Contact
Chunyu Wang
K number
K233277
Date received
2023-09-29
Review advisory committee
HO
Postal code
311199
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Filter, Infusion Line
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
Registration number
1526534, 2025816, 3012821221, 3010132111, 3030447506, 1416980, 3004569180, 3010173425, 2528981, 8040700, 1057358, 8020892, 3016904853, 3015276780, 3009328501, 3033536319, 1061124, 3012354669, 3006425876, 9680602, 9616567, 3013517171, 3022555290, 3008132398, 3002807315, 1422078, 3003704957, 3008412416, 3003595336, 3043226252, 1718873, 2245270, 3012494290, 1526863, 1319639, 1220477, 1530671, 3013557562, 3002907620, 1423507 +11 more
FEI number
1526534, 3002806588, 1000036860, 2025816, 1000532580, 3012821221, 3010132111, 3002963732, 3030447506, 1000512168, 1416980, 3004569180, 3002807036, 3003737899, 2528981, 3002806443, 1000208608, 3016904853, 3015276780, 3009328501, 3033536319, 1000120555, 3012354669, 3006425876, 3013517171, 3022555290, 1000306431, 3002807315, 3002807091, 3003704957, 3008412416, 3003595336, 3043226252, 1718873, 2245270, 3002807111, 3002807666, 3001639729, 3012494290, 1526863 +11 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.