The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Surgical Gut Suture.
| Device ID | K930944 |
| 510k Number | K930944 |
| Device Name: | LUKENS SURGICAL GUT SUTURE |
| Classification | Suture, Absorbable, Natural |
| Applicant | LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Contact | Brenda Kelly |
| Correspondent | Brenda Kelly LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1993-12-17 |