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FDA · official record K994154Substantially Equivalent

MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES

United StatesJEYKLS-Martin L.P.
Official record identity
FDA application number
K994154
Decision date
February 15, 2000
Published decision
Substantially Equivalent
Classification
Published parties
Additional source fields
Decision code
SESE
Published decision
Substantially Equivalent
Submission type
Traditional
Received date
1999-12-09
Review panel
Dental
Current product-code class (harmonized)
2
Current product-code regulation (harmonized)
872.4760
About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.