The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Expanded Poly. Card. Patch 0.6 And 0.4mm.
| Device ID | K912107 |
| 510k Number | K912107 |
| Device Name: | GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-13 |
| Decision Date | 1991-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132600748 | K912107 | 000 |
| 00733132600649 | K912107 | 000 |
| 00733132600656 | K912107 | 000 |
| 00733132600663 | K912107 | 000 |
| 00733132600670 | K912107 | 000 |
| 00733132600687 | K912107 | 000 |
| 00733132600694 | K912107 | 000 |
| 00733132600700 | K912107 | 000 |
| 00733132600717 | K912107 | 000 |
| 00733132600724 | K912107 | 000 |
| 00733132600731 | K912107 | 000 |
| 00733132600632 | K912107 | 000 |