510(k) K152609
- Device
- GORE SYNECOR Biomaterial
- Applicant
- W.L GORE & ASSOCIATES, INC.
- 510(k) number
- K152609
- Product code
- FTL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-11
- Date received
- 2015-09-14
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Polymeric
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- 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
- BARBARA L. SMITH
- Address
- 301 Airport Rd. Elkton MD US 21921 21921
FDA Registration Numbers
- 3013111980
- 3010034780
- 1649390
- 1061124
- 3032412536
- 3002807315
- 3003936139
- 3011582224
- 3004464325
- 2648650
- 9617465
- 3015453963
- 3010291427
- 3013188547
- 8044102
- 1018470
- 3003910212
- 3009749957
- 3005636544
- 8043484
- 2031093
- 1061771
- 3010131137
- 1423537
- 1721676
- 3017492634
- 1064858
- 3017210488
- 2024024
- 3010513348
- 3017196117
- 1018233
- 3009756327
- 3010237768
- 8010177
- 3006121828
- 3030733800
- 3006174295
- 2435947
- 3010331645
- 1422634
- 3015860534
- 3010187263
- 2530154
- 3015231789
- 3002808022
- 3014279513
- 3039256597
- 3004944585
- 1058584
- 3009217531
- 1835959
- 1226146
- 3030412764
- 3002807310
- 3002807523
- 2031966
- 3007663067
- 3009417901
- 3020983460
- 9614846
- 8020712
- 3009514842
- 1000393132
- 1526534
- 3002807295
- 3027616027
- 1319639
- 9615742
- 3008812560
- 3021632375
- 3010383847
- 3033302333
- 3005953126
- 3002807561
- 1220246
- 3005941719
- 3004661493
- 3022140316
- 3024021261
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00733132635382 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2016-03-30 |
| 00733132635375 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2016-03-30 |
| 00733132635368 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2016-03-30 |
| 00733132635351 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2016-03-30 |
| 00733132635344 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2016-03-30 |
Legacy Summary
summary
FDA Review
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