The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Safeside(tm) Lumed.
| Device ID | K871546 |
| 510k Number | K871546 |
| Device Name: | SAFESIDE(TM) LUMED |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 1940 E. OCCIDENTAL ST. Santa Ana, CA 92705 |
| Contact | Ronald B Luther |
| Correspondent | Ronald B Luther LUTHER MEDICAL PRODUCTS, INC. 1940 E. OCCIDENTAL ST. Santa Ana, CA 92705 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-06-17 |