The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Sep-pak Cartridges (liquid Chromatography).
Device ID | K864267 |
510k Number | K864267 |
Device Name: | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) |
Classification | Columns, Liquid Chromatography |
Applicant | MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
Contact | Marquand Ransom |
Correspondent | Marquand Ransom MILLIPORE CORP. 34 MAPLE ST. Milford, MA 01757 |
Product Code | DPM |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-29 |
Decision Date | 1987-01-09 |