FDA.reportPublic FDA data

510(k) K082204

Device
SERIES SY DISPOSABLE ELECTROSURGICAL PAD
Applicant
VENTLAB CORP.
510(k) number
K082204
Product code
ODR  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-13
Date received
2008-08-05
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
Statement
Third party reviewed
Yes

Applicant Contact#

Contact
CHRISTINA NORRIS
Address
1676 Village Green Suite A Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K121268WANDY DISPERSVIE ELECTRODEBio-Med USA, Inc.2012-12-20

Legacy Summary#

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

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