The following data is part of a premarket notification filed by Future Medical Systems, Inc. with the FDA for Endo Fms Urology.
| Device ID | K980808 |
| 510k Number | K980808 |
| Device Name: | ENDO FMS UROLOGY |
| Classification | System, Irrigation, Urological |
| Applicant | FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
| Contact | Patrick Janin |
| Correspondent | Patrick Janin FUTURE MEDICAL SYSTEMS, INC. 504 MCCORMICK DR., SUITE T Glen Burnie, MD 21061 |
| Product Code | LJH |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1998-05-08 |