Cleared Traditional

BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE

K894791 · Span-America Medical Systems, Inc. · General Hospital
Oct 1989
Decision
67d
Days
—
Risk

About This 510(k) Submission

K894791 is an FDA 510(k) clearance for the BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE, a Pad, Alcohol, Device Disinfectant, submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on October 3, 1989, 67 days after receiving the submission on July 28, 1989. This device falls under the General Hospital review panel.

Submission Details

510(k) Number K894791 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1989
Decision Date October 03, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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