The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Centry 2 Variable Concentrate-18-.
| Device ID | K802895 |
| 510k Number | K802895 |
| Device Name: | COBE CENTRY 2 VARIABLE CONCENTRATE-18- |
| Classification | Instrument, Surgical, Disposable |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1980-12-22 |