The following data is part of a premarket notification filed by Cobe Renal Care, Inc. with the FDA for Gambro Lundia Pro 100, 500, 600 Dialyzers.
Device ID | K933681 |
510k Number | K933681 |
Device Name: | GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS |
Classification | Dialyzer, Parallel Flow |
Applicant | COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
Contact | Jeffrey R Shideman |
Correspondent | Jeffrey R Shideman COBE RENAL CARE, INC. 1185 OAK ST. Lakewood, CO 80215 -4407 |
Product Code | FJG |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-29 |
Decision Date | 1994-09-07 |