FDA.report

510(k) K140195

Device
SURGICAL DRAPE
Applicant
GRIFFITH-LUCAS LLC
510(k) number
K140195
Product code
KKX  
Decision
Substantially Equivalent (SESE)
Decision date
2014-09-10
Date received
2014-01-27
Regulation
878.4370
Classification name
Drape, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MIKE GU
Address
7th Floor, Jingui Business Bldg., #982 Congyun Rd. Baiyun District Guangzhou, Guangdong CN 510420 510420

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases