FDA.reportPublic FDA data

510(k) K121268

Device
WANDY DISPERSVIE ELECTRODE
Applicant
BIO-MED USA INC.
510(k) number
K121268
Product code
ODR  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-20
Date received
2012-04-26
Regulation
878.4400
Classification name
Electrosurgical Patient Return Electrode
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YOUNG CHI
Address
111 Ellison St. Paterson NJ US 07505 07505

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160366Electrosurgical disposable grounding padsTop-Rank Health Care Co., Ltd.2016-08-19
K082204SERIES SY DISPOSABLE ELECTROSURGICAL PADVentlab Corp.2008-08-13

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