The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centriprep 100.
Device ID | K900280 |
510k Number | K900280 |
Device Name: | CENTRIPREP 100 |
Classification | Electrode, Ion Selective (non-specified) |
Applicant | AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
Contact | James M Delaney |
Correspondent | James M Delaney AMICON, INC. 17 CHERRY HILL DR. Danvers, MA 01923 |
Product Code | JJP |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-18 |
Decision Date | 1990-02-16 |