The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Regenerative Material.
| Device ID | K922627 |
| 510k Number | K922627 |
| Device Name: | GORE-TEX REGENERATIVE MATERIAL |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86001 |
| Contact | Mary Edwards |
| Correspondent | Mary Edwards 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 | 1992-06-03 |
| Decision Date | 1994-06-10 |