Cleared Traditional

K890514 - PRE-MOISTENED CLEANSING PAD (FDA 510(k) Clearance)

K890514 · Bausch & Lomb, Inc. · General Hospital
Apr 1989
Decision
68d
Days
-
Risk

K890514 is an FDA 510(k) clearance for the PRE-MOISTENED CLEANSING PAD. This device is classified as a Pad, Alcohol, Device Disinfectant.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on April 10, 1989, 68 days after receiving the submission on February 1, 1989.

This device falls under the General Hospital FDA review panel.

Submission Details

510(k) Number K890514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date April 10, 1989
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -

Device Classification

Product Code LKB - Pad, Alcohol, Device Disinfectant
Device Class -