FDA · official record K905470Substantially Equivalent

STANDARD RUBBER DAM WITH OR WITHOUT FRAMES

Name: STANDARD RUBBER DAM WITH OR WITHOUT FRAMES — FDA K905470
Creator: Elastomade Accessories Sdn Bhd
Keywords: STANDARD RUBBER DAM WITH OR WITHOUT FRAMES, STANDARD RUBBER DAM WITH OR WITHOUT FRAMES, K905470, EIE, FDA

United StatesEIEElastomade Accessories Sdn Bhd

Verified

Official record identity

FDA application number: K905470
Decision date: April 25, 1991
Published decision: Substantially Equivalent

Classification

Product code: EIE

Published parties

Applicant: Elastomade Accessories Sdn Bhd

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1990-12-06
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.