The following data is part of a premarket notification filed by Amicon, Inc. with the FDA for Centricon Concentrator.
Device ID | K893733 |
510k Number | K893733 |
Device Name: | CENTRICON CONCENTRATOR |
Classification | Clinical Sample Concentrator |
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 | JJH |
CFR Regulation Number | 862.2310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-17 |
Decision Date | 1989-07-20 |