The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Ren New-d Dispensing Kit.
| Device ID | K853817 |
| 510k Number | K853817 |
| Device Name: | COBE REN NEW-D DISPENSING KIT |
| Classification | Dialyzer Reprocessing System |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-12 |
| Decision Date | 1985-10-17 |