The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Centry 2 System #016, 103, 016, 104.
| Device ID | K791086 |
| 510k Number | K791086 |
| Device Name: | CENTRY 2 SYSTEM #016, 103, 016, 104 |
| Classification | Subsystem, Water Purification |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-12 |
| Decision Date | 1979-07-03 |