The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Hewson Ligament Button.
Device ID | K792004 |
510k Number | K792004 |
Device Name: | HEWSON LIGAMENT BUTTON |
Classification | Retention Device, Suture |
Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-03 |
Decision Date | 1979-11-05 |