The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Ppd 1.3l, #18-520-009.
| Device ID | K820694 |
| 510k Number | K820694 |
| Device Name: | COBE PPD 1.3L, #18-520-009 |
| Classification | Dialyzer, Parallel Flow |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-12 |
| Decision Date | 1982-03-31 |