NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)— 510(k) K972039

Name: FDA 510(k) clearance K972039
Creator: U.S. Food and Drug Administration
Published: 1997-08-25

Substantially Equivalent

Nu-Sound

FDA 510(k) clearance K972039 for NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC), Substantially Equivalent on 1997-08-25. Applicant: Nu-Sound. Device class: 1.

Clearance details

Applicant: Nu-Sound
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1997-06-02
Decision date: 1997-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.