The following data is part of a premarket notification filed by Ludwig Medical, Inc. with the FDA for Tubes, Lukens, Tomas.
| Device ID | K781234 |
| 510k Number | K781234 |
| Device Name: | TUBES, LUKENS, TOMAS |
| Classification | Bottle, Collection, Vacuum |
| Applicant | LUDWIG MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-19 |
| Decision Date | 1978-08-10 |