Cleared Traditional

WARMTOUCH PLASTIC WARMING COVER

K943276 · Mallinckrodt Medical · Cardiovascular

Sep 1994

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K943276 is an FDA 510(k) clearance for the WARMTOUCH PLASTIC WARMING COVER, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on September 19, 1994, 74 days after receiving the submission on July 7, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K943276 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1994
Decision Date	September 19, 1994
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).