FDA · official record K982009Substantially Equivalent

ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE

Name: ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE — FDA K982009
Creator: Scitech Solutions, Inc.
Keywords: ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE, ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE, K982009, EIA, FDA

United StatesEIAScitech Solutions, Inc.

Verified

Official record identity

FDA application number: K982009
Decision date: June 25, 1998
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Scitech Solutions, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1998-04-02
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.