Cleared Traditional

DERMATHERAPY, MODEL 22216

K061242 · Precision Fabrics Group, Inc. · General Hospital

Jan 2007

Decision

267d

Days

Class 1

Risk

About This 510(k) Submission

K061242 is an FDA 510(k) clearance for the DERMATHERAPY, MODEL 22216, a Cover, Mattress (medical Purposes) (Class I — General Controls, product code FMW), submitted by Precision Fabrics Group, Inc. (Norfolk, US). The FDA issued a Cleared decision on January 25, 2007, 267 days after receiving the submission on May 3, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6190.

Submission Details

510(k) Number	K061242 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2006
Decision Date	January 25, 2007
Days to Decision	267 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF