The following data is part of a premarket notification filed by Li Medical Technologies, Inc. with the FDA for Lm Anchor.
| Device ID | K981764 |
| 510k Number | K981764 |
| Device Name: | LM ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| Subsequent Product Code | GAT |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854040338 | K981764 | 000 |