The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for Liquid Chromatography Columns Hisep Column & Guard.
Device ID | K881868 |
510k Number | K881868 |
Device Name: | LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD |
Classification | Columns, Liquid Chromatography |
Applicant | SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Contact | Lloyd A Witting,phd |
Correspondent | Lloyd A Witting,phd SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Product Code | DPM |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-03 |
Decision Date | 1988-08-29 |