Cleared Traditional

BAXTER ACETONE-ALCOHOL PREP PADS, STERILE

K893958 · Span-America Medical Systems, Inc. · General Hospital
Oct 1989
Decision
124d
Days
—
Risk

About This 510(k) Submission

K893958 is an FDA 510(k) clearance for the BAXTER ACETONE-ALCOHOL PREP PADS, 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, 124 days after receiving the submission on June 1, 1989. This device falls under the General Hospital review panel.

Submission Details

510(k) Number K893958 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1989
Decision Date October 03, 1989
Days to Decision 124 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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