The following data is part of a premarket notification filed by Hysterx, Inc. with the FDA for Liga-loop Suture Applicator.
| Device ID | K993695 |
| 510k Number | K993695 |
| Device Name: | LIGA-LOOP SUTURE APPLICATOR |
| Classification | Suture, Absorbable, Natural |
| Applicant | HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon HYSTERX, INC. 18732 SAGINAW Irvine, CA 92612 |
| Product Code | GAL |
| Subsequent Product Code | GAM |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GEA |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-02 |
| Decision Date | 2000-04-13 |
| Summary: | summary |