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510(k) K093587

Device
DENTAL MERCURY
Applicant
DMG USA, INC.
510(k) number
K093587
Product code
ELY  
Decision
Substantially Equivalent (SESE)
Decision date
2010-01-21
Date received
2009-11-19
Regulation
872.3070
Classification name
Mercury
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAMELA PAPINEAU
Address
23 Frank Mossberg Dr. Attleboro MA US 02703 02703

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973548MERCURY DENTALAleaciones Dentales Zeyco, S.A. DE C.V.1998-03-23
K913814MODEL #05 ANEROID SPHYGMOMANOMETER KITNational Health-Care Equipment, Inc.1992-01-16
K902388DENTAL-QUECKSILBER (DENTAL MERCURY)Degussa AG1990-06-28

Legacy Summary#

summary

FDA Review#

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