TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER— 510(k) K053430

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K053430 for TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER, Substantially Equivalent on 2006-03-03. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code HKY
Advisory panel: Ophthalmic
Date received: 2005-12-09
Decision date: 2006-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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