OTOVIEW ENDOSCOPY SYSTEM— 510(k) K934432

Name: FDA 510(k) clearance K934432
Creator: U.S. Food and Drug Administration
Published: 1994-04-25

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K934432 for OTOVIEW ENDOSCOPY SYSTEM, Substantially Equivalent on 1994-04-25. Applicant: Smith & Nephew Richards, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code EWA
Device class: Class 1
Regulation: 21 CFR 874.1080
Advisory panel: Ear, Nose, Throat
Date received: 1993-09-13
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

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