510(k) K895105

HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE by Waters Chemical Products — Product Code DPM

K895105 is an FDA 510(k) premarket notification submitted by Waters Chemical Products for the device "HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code DPM (Columns, Liquid Chromatography), a Class I device regulated under 21 CFR 862.2260. Waters Chemical Products has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Columns, Liquid Chromatography
Device Class
Class I
Regulation Number
862.2260
Review Panel
TX
Submission Type