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 |