The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Diaclear Ultrafilter.
| Device ID | K003957 |
| 510k Number | K003957 |
| Device Name: | DIACLEAR ULTRAFILTER |
| Classification | Subsystem, Water Purification |
| Applicant | GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Contact | Suzanne Dennis |
| Correspondent | Suzanne Dennis GAMBRO RENAL PRODUCTS 10810 W. COLLINS AVE. Lakewood, CO 80215 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414066315 | K003957 | 000 |