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510(k) K973548

Device
MERCURY DENTAL
Applicant
ALEACIONES DENTALES ZEYCO, S.A. DE C.V.
510(k) number
K973548
Product code
ELY  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-23
Date received
1997-09-18
Regulation
872.3070
Classification name
Mercury
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JORGE ZEPEDA GALVEZ
Address
Calz. Lazaro Cardenas #2838 Col. Jardines Del Bosque Guadalajara MX 44520 44520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K093587DENTAL MERCURYDmg USA, Inc.2010-01-21
K913814MODEL #05 ANEROID SPHYGMOMANOMETER KITNational Health-Care Equipment, Inc.1992-01-16
K902388DENTAL-QUECKSILBER (DENTAL MERCURY)Degussa AG1990-06-28

Legacy Summary#

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FDA Review#

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