510(k) K022057
- Device
- KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX
- Applicant
- Kyung GI Medical Ind. Co., Ltd.
- 510(k) number
- K022057
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-11-22
- Date received
- 2002-06-24
- Regulation
- 880.5570
- Classification name
- Needle, Hypodermic, Single Lumen
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- BYUNG DOO JEE
- Address
- 529-4 Yulsaeng-Ri Daegot-Myun Kimpo-Si, Kyunggi-Do KR 4152367 4152367
FDA Registration Numbers#
- 3000214934
- 1450392
- 3022699058
- 3013221738
- 3014649053
- 3018507299
- 1722458
- 3019012929
- 3009498548
- 3010041511
- 1923569
- 1219611
- 3017494520
- 3008729892
- 3008729549
- 3014819517
- 3014165712
- 3043531632
- 3010131137
- 9610847
- 3026478941
- 3007895168
- 3008449424
- 8010026
- 1058602
- 3018681450
- 3010220595
- 1417485
- 2245270
- 3007384659
- 3020831613
- 8041187
- 3008780388
- 3017509841
- 3007392007
- 3013481097
- 3013187142
- 3007590959
- 9614279
- 9615588
- 3005669815
- 3007207906
- 3010175289
- 1313700
- 3031259044
- 3012680643
- 3007939342
- 3021186226
- 9615908
- 1035236
- 3012551896
- 1319211
- 1820334
- 3003915875
- 3015058854
- 3003895930
- 9616567
- 3006942524
- 3004192065
- 3013557562
- 3011689956
- 3023339256
- 3030201489
- 3007829657
- 3014747754
- 8041145
- 3009746061
- 1066741
- 1417592
- 1450743
- 1625685
- 3023359743
- 3006371704
- 9681835
- 3008009298
- 3031233007
- 8043385
- 3001728571
- 8020040
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FMI#
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| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 |
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