OVATION ASP— 510(k) K963819

Substantially Equivalent

Orsonique, Inc.

FDA 510(k) clearance K963819 for OVATION ASP, Substantially Equivalent on 1996-10-28. Applicant: Orsonique, Inc.. Device class: 1.

Clearance details

Applicant: Orsonique, Inc.
Product code: Code ESD
Device class: Class 1
Regulation: 21 CFR 874.3300
Advisory panel: Ear, Nose, Throat
Date received: 1996-09-23
Decision date: 1996-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, Quebec, CA

Download summary PDF View on FDA.gov ↗

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