The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Sterile 100% Silicone Foley Catheter.
| Device ID | K780675 |
| 510k Number | K780675 |
| Device Name: | STERILE 100% SILICONE FOLEY CATHETER |
| Classification | Catheter, Urological |
| Applicant | MEDLINE INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-24 |
| Decision Date | 1978-05-09 |