The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Silk Surgical Suture.
Device ID | K930942 |
510k Number | K930942 |
Device Name: | LUKENS SILK SURGICAL SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
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 | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-23 |
Decision Date | 1993-12-17 |