FDA · official record K842844Substantially Equivalent

DENTI-D RUBBER DAM

Name: DENTI-D RUBBER DAM — FDA K842844
Creator: Fema Corp.
Keywords: DENTI-D RUBBER DAM, DENTI-D RUBBER DAM, K842844, EIE, FDA

United StatesEIEFema Corp.

Verified

Official record identity

FDA application number: K842844
Decision date: August 17, 1984
Published decision: Substantially Equivalent

Classification

Product code: EIE

Published parties

Applicant: Fema Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1984-07-20
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6300

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.