The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Ultrasorb Suture Anchor.
| Device ID | K002413 |
| 510k Number | K002413 |
| Device Name: | ULTRASORB SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
| Contact | Rhodemann Li |
| Correspondent | Rhodemann Li LI MEDICAL TECHNOLOGIES, INC. 4 ARMSTRONG RD. Shelton, CT 06484 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-09-19 |