The following data is part of a premarket notification filed by Atrix Laboratories, Inc. with the FDA for Atrisorb-d Freeflow Bioabsorbable Guided Tissue Regeneration (gtr) Barrier With 4% Doxycycline.
| Device ID | K994137 |
| 510k Number | K994137 |
| Device Name: | ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | ATRIX LABORATORIES, INC. 2579 MIDPOINT DR. Fort Collins, CO 80525 -4417 |
| Contact | Amy Taylor |
| Correspondent | Amy Taylor ATRIX LABORATORIES, INC. 2579 MIDPOINT DR. Fort Collins, CO 80525 -4417 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-07 |
| Decision Date | 2000-09-13 |
| Summary: | summary |