FDA · official record K971887Substantially Equivalent

BREATH TAKER

Name: BREATH TAKER — FDA K971887
Creator: Hofa, LLC
Keywords: BREATH TAKER, BREATH TAKER, K971887, LCN, FDA

United StatesLCNHofa, LLC

Verified

Official record identity

FDA application number: K971887
Decision date: June 10, 1997
Published decision: Substantially Equivalent

Classification

Product code: LCN

Published parties

Applicant: Hofa, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-05-21
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6855

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.