The following data is part of a premarket notification filed by Lukens Corp. with the FDA for Lukens Bone Wax (gamma Radiation).
| Device ID | K791495 |
| 510k Number | K791495 |
| Device Name: | LUKENS BONE WAX (GAMMA RADIATION) |
| Classification | Wax, Bone |
| Applicant | LUKENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-03 |
| Decision Date | 1979-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782008251 | K791495 | 000 |
| 10848782008244 | K791495 | 000 |
| 10848782005618 | K791495 | 000 |
| 10848782005601 | K791495 | 000 |