Cleared Traditional

STERI-SWAB

K912731 · Westlock Investments (Usa), Inc. · General Hospital
Oct 1991
Decision
104d
Days
—
Risk

About This 510(k) Submission

K912731 is an FDA 510(k) clearance for the STERI-SWAB, a Pad, Alcohol, Device Disinfectant, submitted by Westlock Investments (Usa), Inc. (Bellevue, US). The FDA issued a Cleared decision on October 2, 1991, 104 days after receiving the submission on June 20, 1991. This device falls under the General Hospital review panel.

Submission Details

510(k) Number K912731 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1991
Decision Date October 02, 1991
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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