The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Regenerative Material Titanium Reinforced Configurations.
| Device ID | K960292 |
| 510k Number | K960292 |
| Device Name: | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86001 |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86001 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-22 |
| Decision Date | 1996-04-15 |
| Summary: | summary |