The following data is part of a premarket notification filed by Urol, Inc. with the FDA for Specimen Collection Device.
| Device ID | K780049 |
| 510k Number | K780049 |
| Device Name: | SPECIMEN COLLECTION DEVICE |
| Classification | Container, Specimen, Sterile |
| Applicant | UROL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMH |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-09 |
| Decision Date | 1978-01-26 |