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FDA · official record K922673Substantially Equivalent

FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING

United StatesELSGlasspan, Inc.
Official record identity
FDA application number
K922673
Decision date
February 25, 1994
Published decision
Substantially Equivalent
Classification
Published parties
Additional source fields
Decision code
SESE
Published decision
Substantially Equivalent
Submission type
Traditional
Received date
1992-06-04
Review panel
Dental
Current product-code class (harmonized)
2
Current product-code regulation (harmonized)
872.3890
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.