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FDA · official record K930144Substantially Equivalent

THE SCITECH ONE-DAY FILTER

United StatesEIAScitech Solutions, Inc.
Official record identity
FDA application number
K930144
Decision date
February 22, 1994
Published decision
Substantially Equivalent
Classification
Published parties
Additional source fields
Decision code
SESE
Published decision
Substantially Equivalent
Submission type
Traditional
Received date
1993-01-12
Review panel
Dental
Current product-code class (harmonized)
1
Current product-code regulation (harmonized)
872.6640
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.