The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Polypropylene Monofilament Nonabsorbable.
| Device ID | K930941 |
| 510k Number | K930941 |
| Device Name: | LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| 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 | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1993-12-17 |