OTOVIEW TELESCOPIC OTOSCOPES— 510(k) K943721

Name: FDA 510(k) clearance K943721
Creator: U.S. Food and Drug Administration
Published: 1994-11-18

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K943721 for OTOVIEW TELESCOPIC OTOSCOPES, Substantially Equivalent on 1994-11-18. Applicant: Smith & Nephew, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1994-08-01
Decision date: 1994-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

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