FDA · official record K925064Substantially Equivalent for Some Indications

RELAX-O-GUARD

Name: RELAX-O-GUARD — FDA K925064
Creator: Aquatemp Service Co., Inc.
Keywords: RELAX-O-GUARD, RELAX-O-GUARD, K925064, KMY, FDA

United StatesKMYAquatemp Service Co., Inc.

Verified

Official record identity

FDA application number: K925064
Decision date: September 13, 1993
Published decision: Substantially Equivalent for Some Indications

Classification

Product code: KMY

Published parties

Applicant: Aquatemp Service Co., Inc.

Additional source fields

Decision code: SN
Published decision: Substantially Equivalent for Some Indications
Submission type: Traditional
Received date: 1992-10-06
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.5525

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.