The following data is part of a premarket notification filed by Gambro Services, Inc. with the FDA for Gambro Posiclear.
| Device ID | K061782 |
| 510k Number | K061782 |
| Device Name: | GAMBRO POSICLEAR |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO SERVICES, INC. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Contact | Jeffery R Shideman |
| Correspondent | Jeffery R Shideman GAMBRO SERVICES, INC. 7307 GLOUCHESTER DRIVE Edina, MN 55435 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2007-01-04 |
| Summary: | summary |