510(k) K984534
- Device
- PRECLUDE ACUSEAL DURA SUBSTITUTE
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K984534
- Product code
- GXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-15
- Date received
- 1998-12-21
- Regulation
- 882.5910
- Classification name
- Dura Substitute
- Medical specialty
- Neurology
- Review panel
- Neurology
- 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
- JOHN NICHOLSON
- Address
- 301 Airport Rd. Elkton MD US 21922 21922
FDA Registration Numbers
- 2916714
- 2245304
- 1416980
- 2249852
- 2650143
- 3027448274
- 1121308
- 3004464325
- 3012448339
- 3009039068
- 3025316685
- 3003300673
- 3012421607
- 3020659113
- 3035387162
- 3004170064
- 9681465
- 3008812560
- 1835959
- 3034676720
- 3006017180
- 1225991
- 9610612
- 3004681519
- 3009417901
- 3007284313
- 3002924436
- 3012479318
- 3000270450
- 1319660
- 1220948
- 1000393132
- 2183620
- 3002294946
- 3003418325
- 3002719998
- 1319639
- 3030126381
- 3012429393
- 2648988
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132601981 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2017-02-13 |
| 00733132602001 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132601998 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132601974 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132601967 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132601950 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
| 00733132601943 | GORE PRECLUDE PDX Dura Substitute | W. L. Gore & Associates, Inc. | 2016-03-07 |
Legacy Summary
summary
FDA Review
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