Cleared Traditional

HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE

K895105 · Waters Chemical Products · Chemistry

Oct 1989

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K895105 is an FDA 510(k) clearance for the HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE, a Columns, Liquid Chromatography (Class I — General Controls, product code DPM), submitted by Waters Chemical Products (Milford, US). The FDA issued a Cleared decision on October 6, 1989, 52 days after receiving the submission on August 15, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number	K895105 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1989
Decision Date	October 06, 1989
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—