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510(k) K211667

Device
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Applicant
Changzhou Universal Medical Equipment Co. Ltd
510(k) number
K211667
Product code
LAZ  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-23
Date received
2021-06-01
Regulation
862.3280
Classification name
N-acetylprocainamide Control Materials
Medical specialty
Toxicology
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jerry Gao
Address
# 6, Xinxi Rd., Xinbei District Changzhou CN 213000 213000

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K851474VYGON SPINAL ANESTHESIA TRAY CODE NO. 190Vygon Corp.1985-05-07
K823127ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYLSyva Co.1982-11-29
K811461EMIT-AND METHOTREXATE CONTROLSyva Co.1981-06-09

Legacy Summary#

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FDA Review#

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