The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Plasmapooler.
Device ID | K801219 |
510k Number | K801219 |
Device Name: | PLASMAPOOLER |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | NORTH AMERICAN BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-21 |
Decision Date | 1980-10-31 |