510(k) K220794
- Device
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- Applicant
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- 510(k) number
- K220794
- Product code
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- Decision
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- Decision date
- 2022-11-10
- Date received
- 2022-03-18
- Regulation
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- Classification name
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- Medical specialty
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- Review panel
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- Device class
- 2
- Clearance type
- Error Temporari
- Statement or summary
- Summary
- Third party reviewed
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Related Records
Applicant Contact
- Contact
- Lee Dong Gun
- Address
- 3f Hyungkyung Bldg., 611, Seolleung-Ro Gangnam-Gu KR 06103 06103
FDA Registration Numbers
- 3009736547
- 3010511300
- 3041275224
- 3007238544
- 3008442971
- 3006555617
- 3043657394
- 3009040934
- 3026540840
- 3043655996
- 3012133441
- 3004635398
- 3025104654
- 3006515340
- 3032147807
- 3012799115
- 3008915316
- 2953696
- 3021011208
- 3043047259
- 3033482500
- 3033884002
- 3010912900
- 3021349626
- 3033273466
- 9680762
- 3004069780
- 3033715699
- 3005238200
- 3015452693
- 3010273872
- 3016076698
- 3030230686
- 3006716777
- 3002808227
- 1313525
- 8040564
- 3011964664
- 3010902869
- 3016661372
- 3017905264
- 3021334828
- 3005695724
- 3011782009
- 3005855240
- 3025606176
- 3027645761
- 3027605738
- 3043011436
- 3009019578
- 3012772112
- 3022327202
- 3016496662
- 3009444646
- 3033891767
- 3037874486
- 3007113239
- 3034246188
- 3013494333
- 3011670002
- 3007120647
- 3033793026
- 3001431138
- 3006580954
- 3017619615
- 3033844600
- 3034995492
- 3043140693
- 3038715747
- 3006985163
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- 3023281259
- 3009488834
- 3027725665
- 3003542872
- 3011307265
- 2031934
- 3043012240
- 1222304
- 3007085226
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809709380435 | 10PL | TENTECH Inc. | 2024-06-28 |
| 08809709380411 | 10PL | TENTECH Inc. | 2024-06-28 |