510(k) K872112
- Device
- XOMED PLATINUM WIRE TEFLON PISTION
- Applicant
- XOMED, INC.
- 510(k) number
- K872112
- Product code
- ETB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-07-02
- Date received
- 1987-06-01
- Regulation
- 874.3450
- Classification name
- Prosthesis, Partial Ossicular Replacement
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- GORDON PETERS
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3017636737
- 1045254
- 1048735
- 8010617
- 3003790304
- 1052728
- 3001239363
- 8044131
- 2020550
- 3006849754
- 3008812251
- 9612501
- 3009217531
- 1057421
- 9710014
- 3008132398
- 3011050570
- 3002858762
- 3010202439
- 9610617
- 1928237
- 3014342096
- 1037007
- 3018094310
- 9616949
- 3010707607
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000035358 | Causse | MEDTRONIC XOMED, INC. | 2021-11-07 |
| 00763000035419 | Causse | MEDTRONIC XOMED, INC. | 2021-11-07 |
| 00763000035426 | Causse | MEDTRONIC XOMED, INC. | 2021-11-07 |
| 00681490035514 | Causse | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035248 | NA | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035262 | Fisch | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035286 | Fisch | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035293 | Causse | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035316 | NA | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035323 | NA | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035330 | NA | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035347 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035354 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035385 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035392 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035521 | Causse | MEDTRONIC XOMED, INC. | 2015-06-23 |
| 00681490035309 | NA | MEDTRONIC XOMED, INC. | 2015-06-22 |
| 00681490035279 | Fisch | MEDTRONIC XOMED, INC. | 2015-06-22 |
| 00681490035361 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-22 |
| 00681490035255 | NA | MEDTRONIC XOMED, INC. | 2015-06-22 |
| 00681490035378 | Del La Cruz | MEDTRONIC XOMED, INC. | 2015-06-22 |
| 00681490035231 | NA | MEDTRONIC XOMED, INC. | 2015-06-22 |
Legacy Summary
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FDA Review
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