DermaTherapy Bed Linens
K-Number: K152884 · 2016-06-20
ApplicantPrecision Fabrics Group, Inc.
Decision Date2016-06-20
Product CodeFMW
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
DermaTherapy Bed Linens is the device name listed in this FDA 510(k) record. The listed applicant is Precision Fabrics Group, Inc.. It received FDA 510(k) clearance on 2016-06-20 under 510(k) number K152884. The device is classified under product code FMW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DermaTherapy Bed Linens?
DermaTherapy Bed Linens is a medical device that received FDA 510(k) clearance on 2016-06-20. The listed applicant is Precision Fabrics Group, Inc.. The 510(k) number is K152884.
When did DermaTherapy Bed Linens receive FDA 510(k) clearance?
DermaTherapy Bed Linens received FDA 510(k) clearance on 2016-06-20, under 510(k) number K152884.
Who is the listed applicant for DermaTherapy Bed Linens?
The FDA 510(k) record lists Precision Fabrics Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DermaTherapy Bed Linens?
The FDA product code for DermaTherapy Bed Linens is FMW.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.