510(k) clearances

Disposable infusion set with needle

Shandong Zhushi Pharmaceutical Group Co., Ltd. · General Hospital

K232475Substantially EquivalentTraditionalFPA
Open FDA's page for this record
Third party flag
N
City
Heze
Advisory committee description
General Hospital
Address 1
# 6, Shande Rd., Shan County
Statement or summary
Summary
Product code
FPA
Zip code
274300
Applicant
Shandong Zhushi Pharmaceutical Group Co., Ltd.
Decision date
2024-05-10
Decision code
SESE
Country code
CN
Device name
Disposable infusion set with needle
Advisory committee
HO
Contact
Junhui Zhu
K number
K232475
Date received
2023-08-16
Review advisory committee
HO
Postal code
274300
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Set, Administration, Intravascular
Medical specialty description
General Hospital
Regulation number
880.5440
Device class
2
Registration number
3003700453, 8021545, 3009456923, 1000523114, 3002806603, 2029015, 3016472589, 3012302888, 3011944170, 9617592, 9611590, 3006425876, 1314417, 3013696225, 3004111573, 3043226252, 3033589330, 3003974574, 9681835, 1000587249, 3044994889, 3044026004, 1833470, 2437459, 2523676, 9610825, 1410248, 3012116434, 3015060216, 3005515211, 8020040, 2025816, 3012187973, 9680425, 3010413216, 3003895440, 3003442380, 3007363456, 3014162214, 3009976527 +390 more
FEI number
3003700453, 1000113359, 3009456923, 1000523114, 3002806603, 3016472589, 3000974732, 3012302888, 1000208624, 1000120555, 3011944170, 3006425876, 1314417, 3013696225, 3932, 3004111573, 3043226252, 3033589330, 3003974574, 1000587249, 3044994889, 3044026004, 3002826093, 3003166194, 2523676, 1410248, 3012116434, 3015060216, 3005515211, 3000147578, 2025816, 3012187973, 3002879021, 3010413216, 3003895440, 1000226372, 3003442380, 3000204695, 3003040625, 3014162214 +390 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.