510(k) K851952
- Device
- Varices Injector
- Applicant
- WILSON-COOK MEDICAL, INC.
- 510(k) number
- K851952
- Product code
- FBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-26
- Date received
- 1985-05-03
- Regulation
- 876.1500
- Classification name
- Endoscopic Injection Needle, Gastroenterology-Urology
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- JON WILSON
- Address
- 4900 Bethania Station Rd. Winston-Salem NC US 27105 27105
FDA Registration Numbers
- 3008573567
- 1722746
- 3006621103
- 3011193403
- 1519132
- 3027269340
- 3009747810
- 3010288205
- 3011146996
- 3012480535
- 3025311469
- 2431166
- 3002647932
- 3035451914
- 1000121056
- 2134494
- 8010047
- 3011050570
- 3010202439
- 1047843
- 3004784537
- 3015895045
- 1018233
- 3007699067
- 1828424
- 9610711
- 3004083736
- 3004837686
- 3005580113
- 3011707784
- 1222168
- 3017448360
- 2183446
- 3010273872
- 3003790304
- 3010515547
- 3008274780
- 3004207966
- 3010419931
- 3004129994
- 3009064553
- 1825146
- 1061927
- 3015142721
- 1037905
- 1643817
- 3015972753
- 3003814961
- 2020550
- 9680809
- 1820334
- 3035434483
- 3014769442
- 3009888344
- 9680001
- 9610614
- 2246552
- 3006750742
- 3017178358
- 3005099803
- 1056129
- 1220592
- 9614641
- 3021632375
- 3021023752
- 1000393132
- 3014620201
- 3005941719
- 3013526170
- 3015042209
- 1647149
- 3013460719
- 3010188783
- 1528319
- 3012649202
- 9681260
- 3007695959
- 3011270181
- 3008797804
- 3012042439
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00827002223912 | Marcon-Haber | COOK INCORPORATED | 2016-09-24 |
| 00827002216495 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002216556 | Marcon-Haber | COOK INCORPORATED | 2016-09-24 |
| 00827002216945 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002216976 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002218246 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002218253 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002218598 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002218666 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002219151 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002219175 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002221000 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002271029 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225756 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225770 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225787 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225794 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225800 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225817 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002225824 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002251489 | Cook | COOK INCORPORATED | 2016-09-24 |
| 00827002257924 | Marcon-Haber | COOK INCORPORATED | 2016-09-24 |
| 00827002271012 | Cook | COOK INCORPORATED | 2016-09-24 |
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