The following data is part of a premarket notification filed by Atrix Laboratories, Inc. with the FDA for Atrisorb Bioabsorbable Guided Tissue Regeneration (gtr) Barrier Kit.
| Device ID | K982865 |
| 510k Number | K982865 |
| Device Name: | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | ATRIX LABORATORIES, INC. 2579 MIDPOINT DR. Fort Collins, CO 80525 -4417 |
| Contact | Elyse Wolff |
| Correspondent | Elyse Wolff ATRIX LABORATORIES, INC. 2579 MIDPOINT DR. Fort Collins, CO 80525 -4417 |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-13 |
| Decision Date | 1998-09-08 |
| Summary: | summary |