Cleared Traditional

PREVANTICS DEVICE SWAB

K132380 · Professional Disposables International, Inc. · General Hospital
Aug 2014
Decision
392d
Days
—
Risk

About This 510(k) Submission

K132380 is an FDA 510(k) clearance for the PREVANTICS DEVICE SWAB, a Pad, Alcohol, Device Disinfectant, submitted by Professional Disposables International, Inc. (Orangeburg, US). The FDA issued a Cleared decision on August 27, 2014, 392 days after receiving the submission on July 31, 2013. This device falls under the General Hospital review panel.

Submission Details

510(k) Number K132380 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2013
Decision Date August 27, 2014
Days to Decision 392 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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