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510(k) K971002

Device
SMILE WITH CONFIDENCE
Applicant
LLOYD V. ZIEMENDORF
510(k) number
K971002
Product code
EHS  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-15
Date received
1997-03-19
Regulation
872.3540
Classification name
Cushion, Denture, Over The Counter
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
LLOYD V ZIEMENDORF
Address
6762 Ward Rd. Niagara Falls NY US 14304 14304

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
K813190SOFT PLATE CUSHIONLeonard Russo Co.1982-02-05
K770413CUSHIONS, DENTURE ADHESIVE, ALL-DAYCombe, Inc.1977-06-24

Legacy Summary#

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FDA Review#

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