The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Anchor System.
| Device ID | K073651 |
| 510k Number | K073651 |
| Device Name: | NEOTRACT ANCHOR SYSTEM |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
| Contact | Suzan Moser |
| Correspondent | Suzan Moser NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-02-01 |
| Summary: | summary |