The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for L-cath Intravenous Placement Unit.
| Device ID | K801575 |
| 510k Number | K801575 |
| Device Name: | L-CATH INTRAVENOUS PLACEMENT UNIT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | LUTHER MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-08 |
| Decision Date | 1980-08-20 |