The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Ellik Bladder Evacuator.
| Device ID | K800397 |
| 510k Number | K800397 |
| Device Name: | ELLIK BLADDER EVACUATOR |
| Classification | Evacuator, Gastro-urology |
| Applicant | SAGE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQT |
| CFR Regulation Number | 876.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-26 |
| Decision Date | 1980-03-10 |