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510(k) K160366

Device
Electrosurgical Disposable Grounding Pads
Applicant
TOP-RANK Health Care Co., Ltd
510(k) number
K160366
Product code
ODR  
Decision
Substantially Equivalent (SESE)
Decision date
2016-08-19
Date received
2016-02-09
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
Liubo Shen
Address
Checun Village, Dongguan St., Shangyu District Shaoxing CN 312352 312352

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
K121268WANDY DISPERSVIE ELECTRODEBio-Med USA, Inc.2012-12-20
K082204SERIES SY DISPOSABLE ELECTROSURGICAL PADVentlab Corp.2008-08-13

Legacy Summary#

summary

FDA Review#

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