510(k) K233284

Device: Vial Adapter with Filter
Applicant: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
510(k) number: K233284
Product code: LHI
Decision: Substantially Equivalent (SESE)
Decision date: 2024-05-01
Date received: 2023-09-29
Regulation: 880.5440
Classification name: Set, I.V. Fluid Transfer
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Chunyu Wang
Address: 104, 301, 302, Bldg. 12, Bldg. 1,619 Wangmei Rd.Inping St., Linping District Hangzhou CN 311199 311199

FDA Registration Numbers

1423662
1450662
2521402
3038356900
3013820501
1423507
8021083
1416980
2650143
1061124
3011392709
1720734
3020706315
3013234390
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1037885
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9615908
1000150646
1035907
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2032098
1018470
3012429465
1019003
2649614
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8031007
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1000163068
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3012307300
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3017636737
2024024
9612052
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1835568
9614279
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1058584
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2953359
1530671
3013561817
3027645738
1713468
3003768277
3013445787
3000223297
1526863
3014579161
3005042488
1417592
1928237
3010329663
1526534
1724474
3002807257
1319639
3003965134
9615050
9610825
2245270
1061927
3011802635
9611665
1056553
3007649127
3002808227
2245590
2245304
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9710643
3006571738
3010160527
3012798826
2030624
3006979803
3010432890
3030446844
1720929
2523676
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1833470
3013764800
1000632857
3007221462
3022555290
2032112
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1223004
1217831
3014312726
1410248
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1643817
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1314417
3002682307
3003974574
3011554160
9610847
2029275
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1048735
3016938816
3015085713
3030201489
8020347
9613744
1000324175
2025816
2520313
2950467
9611157
2244478
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3018503755
3006610642
3043226252
3033527281
9681240
3007829657
3015276780
3008824097
9617594
3009265194
3010512490
2011171
2022435
9617604
1424263
9710018
3007014520
3014936217
3010897183
3007681502
3008729892
3012410077

Source Documents

510(k) summary PDF

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