The following data is part of a premarket notification filed by Urol, Inc. with the FDA for Bacillus Pumilus.
| Device ID | K780974 |
| 510k Number | K780974 |
| Device Name: | BACILLUS PUMILUS |
| Classification | Fiber, Medical, Absorbent |
| Applicant | UROL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRL |
| CFR Regulation Number | 880.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-09 |
| Decision Date | 1978-07-27 |