Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 a medical device manufactured by Precision Fabrics Group, Inc.. It received FDA 510(k) clearance on 2016-06-20 under approval 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. It is manufactured by Precision Fabrics Group, Inc.. The 510(k) number is K152884.

When was DermaTherapy Bed Linens approved by the FDA?

DermaTherapy Bed Linens received FDA 510(k) clearance on 2016-06-20, under approval number K152884.

What company makes DermaTherapy Bed Linens?

DermaTherapy Bed Linens is manufactured by Precision Fabrics Group, Inc..

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.

↑