The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Ppd 1.9.
Device ID | K812336 |
510k Number | K812336 |
Device Name: | COBE PPD 1.9 |
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 | 1981-08-18 |
Decision Date | 1981-08-31 |