The following data is part of a premarket notification filed by Eris Medical Technology with the FDA for Filling Volume Option.
| Device ID | K882295 |
| 510k Number | K882295 |
| Device Name: | FILLING VOLUME OPTION |
| Classification | System, Irrigation, Urological |
| Applicant | ERIS MEDICAL TECHNOLOGY 1308 SPRINGFIELD AVE. New Providence, NJ 07974 |
| Contact | David Suggs |
| Correspondent | David Suggs ERIS MEDICAL TECHNOLOGY 1308 SPRINGFIELD AVE. New Providence, NJ 07974 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-02 |
| Decision Date | 1988-09-13 |