510(k) K961873
- Device
- ACTIVENT ANTIMICROBIAL VENTILATION TUBES
- Applicant
- XOMED, INC.
- 510(k) number
- K961873
- Product code
- ETD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-07-01
- Date received
- 1996-05-15
- Regulation
- 874.3880
- Classification name
- Tube, Tympanostomy
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- DAVID TIMLIN
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3017636737
- 1045254
- 3012130335
- 1048735
- 3008719017
- 8010617
- 3010487482
- 3003790304
- 3010132111
- 3002807315
- 3012266672
- 1052728
- 1519132
- 2183744
- 3012494290
- 3002806953
- 3024021261
- 3010155661
- 3016678045
- 9612501
- 3043226252
- 3009217531
- 3013233645
- 3010610937
- 1057421
- 3006098219
- 3011050570
- 3013557562
- 1928237
- 1926681
- 1037007
- 3018094310
- 3005255160
- 3003678543
- 3012112259
- 1317188
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20681490030995 | Activent® | MEDTRONIC XOMED, INC. | 2015-07-20 |
| 20681490030988 | Sheehy Type Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030971 | Shah Type Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030964 | Shepard Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030940 | Reuter Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030933 | Reuter Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030889 | Moretz Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030841 | Armstrong V Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030520 | Donaldson | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030292 | Armstrong Activent® | MEDTRONIC XOMED, INC. | 2015-07-17 |
| 20681490030865 | Reuter Activent® | MEDTRONIC XOMED, INC. | 2015-07-13 |
| 20681490030780 | Pope Activent® | MEDTRONIC XOMED, INC. | 2015-07-13 |
| 20681490030308 | Armstrong Activent® | MEDTRONIC XOMED, INC. | 2015-07-13 |
| 20681490075910 | Baxter Activent® | MEDTRONIC XOMED, INC. | 2015-07-06 |
Legacy Summary
summary
FDA Review
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