Cleared Traditional

DermaTherapy Bed Linens

K152884 · Precision Fabrics Group, Inc. · General Hospital
Jun 2016
Decision
264d
Days
Class 1
Risk

About This 510(k) Submission

K152884 is an FDA 510(k) clearance for the DermaTherapy Bed Linens, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Precision Fabrics Group, Inc. (Greensboro, US). The FDA issued a Cleared decision on June 20, 2016, 264 days after receiving the submission on September 30, 2015. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number K152884 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date June 20, 2016
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMW — Cover, Mattress (medical Purposes)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6190

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