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510(k) K832500

Device
CS-11
Applicant
CHEMA-SCUTUM, INC.
510(k) number
K832500
Product code
EBE  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-27
Date received
1983-07-27
Regulation
872.3300
Classification name
Coating, Denture Hydrophilic, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830491JOHNSON & JOHNSON OPAQUE COLOR MODIFIJohnson & Johnson Professionals, Inc.1983-03-17
K790339CONCEPT IIRichardson Merrel, Inc.1979-07-17

Legacy Summary#

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FDA Review#

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