The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Anchor System Model: Ref 11208.
| Device ID | K101252 |
| 510k Number | K101252 |
| Device Name: | NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald 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 | 2010-05-04 |
| Decision Date | 2010-07-15 |