Cleared Traditional

I.V. STARR KIT

K912161 · Medical Device Inspection Co., Inc. · General Hospital
Oct 1991
Decision
145d
Days
—
Risk

About This 510(k) Submission

K912161 is an FDA 510(k) clearance for the I.V. STARR KIT, a Pad, Alcohol, Device Disinfectant, submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on October 8, 1991, 145 days after receiving the submission on May 16, 1991. This device falls under the General Hospital review panel.

Submission Details

510(k) Number K912161 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1991
Decision Date October 08, 1991
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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