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510(k) K811665

Device
SR-ISOCETTE
Applicant
J. ADERER, INC.
510(k) number
K811665
Product code
ELK  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-15
Date received
1981-06-15
Regulation
872.3910
Classification name
Teeth, Artificial, Backing And Facing
Medical specialty
Dental
Review panel
Dental
Device class
1
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 ELK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K760909THERMOMETER JARS AND CAPSPlastics/Packaging1976-12-30

Legacy Summary#

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FDA Review#

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