510(k) K021477

Device: PRECLUDE MVP DURA SUBSTITUTE
Applicant: W. L. GORE & ASSOCIATES, INC.
510(k) number: K021477
Product code: GXQ
Decision: Substantially Equivalent (SESE)
Decision date: 2002-11-08
Date received: 2002-05-08
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: TIMOTHY J RYNN
Address: 3450 W. Kiltie Ln. Flagstaff AZ US 86001 86001

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
00733132601493	GORE PRECLUDE MVP Dura Substitute	W. L. Gore & Associates, Inc.	2016-04-29
00733132601486	GORE PRECLUDE MVP Dura Substitute	W. L. Gore & Associates, Inc.	2016-04-29
00733132601479	GORE PRECLUDE MVP Dura Substitute	W. L. Gore & Associates, Inc.	2016-04-29
00733132601462	GORE PRECLUDE MVP Dura Substitute	W. L. Gore & Associates, Inc.	2016-04-29
00733132601455	GORE PRECLUDE MVP Dura Substitute	W. L. Gore & Associates, Inc.	2016-04-29

Legacy Summary

summary

FDA Review

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