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510(k) K813190

Device
SOFT PLATE CUSHION
Applicant
LEONARD RUSSO CO.
510(k) number
K813190
Product code
EHS  
Decision
Substantially Equivalent (SESE)
Decision date
1982-02-05
Date received
1981-11-16
Regulation
872.3540
Classification name
Cushion, Denture, Over The Counter
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 EHS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K971002SMILE WITH CONFIDENCELloyd V. Ziemendorf1997-07-15
K770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYCombe, Inc.1977-06-24

Legacy Summary#

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FDA Review#

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