The following data is part of a premarket notification filed by Millpore Corp. with the FDA for Columns Liquid Chromatography Dpm.
Device ID | K905538 |
510k Number | K905538 |
Device Name: | COLUMNS LIQUID CHROMATOGRAPHY DPM |
Classification | Chromatography (liquid, Gel), Clinical Use |
Applicant | MILLPORE CORP. WATERS CHROMATOGRAPHY DIVISION 34 MAPLE STREET Milford, MA 01757 |
Contact | Marquand S Ransom |
Correspondent | Marquand S Ransom MILLPORE CORP. WATERS CHROMATOGRAPHY DIVISION 34 MAPLE STREET Milford, MA 01757 |
Product Code | KZR |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-11 |
Decision Date | 1991-01-25 |