The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Gambro Central Water Treatment System Cwp 100 - Wro H.
| Device ID | K974899 |
| 510k Number | K974899 |
| Device Name: | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-30 |
| Decision Date | 1998-09-23 |
| Summary: | summary |