The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lu-tex Ii.
| Device ID | K904535 |
| 510k Number | K904535 |
| Device Name: | LU-TEX II |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | LUKENS MEDICAL CORP. 500 LASER RD. Rio Rancho, NM 87124 |
| Contact | M Kelly |
| Correspondent | M Kelly LUKENS MEDICAL CORP. 500 LASER RD. Rio Rancho, NM 87124 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-04 |
| Decision Date | 1991-01-30 |