510(k) K202492
- Device
- EZ-IO Intraosseous Vascular Access System
- Applicant
- Teleflex Medical
- 510(k) number
- K202492
- Product code
- FMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-22
- Date received
- 2020-08-31
- 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
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Rachel Rehl
- Address
- 3015 Carrington Mill Blvd. Morrisville NC US 27560 27560
FDA Registration Numbers
- 1222780
- 3004468406
- 1423537
- 3016685880
- 1221765
- 1063851
- 3012187743
- 3019012929
- 1000484830
- 8041145
- 3009761558
- 3034669683
- 3021169199
- 3014747754
- 9611446
- 2183771
- 3003974574
- 3015997711
- 3008381300
- 8040619
- 3004054016
- 2433012
- 3013633270
- 1054241
- 1928237
- 3006380458
- 3004192065
- 9612057
- 3020831613
- 3009756327
- 1410248
- 3007508552
- 3029755538
- 9681835
- 3008729892
- 2032810
- 1721183
- 9610847
- 9610825
- 9681821
- 1220477
- 3021286079
- 3015176914
- 3010055973
- 3007766601
- 3010160527
- 3014570560
- 3010864832
- 1450743
- 3022699058
- 2243072
- 3007344957
- 1036836
- 9616074
- 9614868
- 1820334
- 1213809
- 3010377171
- 3004961578
- 1417485
- 9612030
- 1061124
- 1526863
- 3012410077
- 3017509841
- 1017768
- 3029901632
- 3006371704
- 3030733800
- 3016904853
- 2320762
- 3005798905
- 3015140199
- 3012104670
- 3013481097
- 3008102042
- 9611680
- 3017494520
- 3015724078
Source Documents
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| K250658 | SureFine Pen Needle | Shina Med Corporation | 2025-04-03 |
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