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FDA · official record K905461Unknown

PROCEDURE KIT/ROUTINE DENTAL PROCEDURES

United StatesEKSAngiosystems, Inc.
Official record identity
FDA application number
K905461
Decision date
March 05, 1991
Published decision
Unknown
Classification
Published parties
Additional source fields
Decision code
SEKD
Published decision
Unknown
Submission type
Traditional
Received date
1990-12-05
Review panel
Dental
Current product-code class (harmonized)
1
Current product-code regulation (harmonized)
872.4565
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.