TONO-PEN TONOMETER TIP COVER— 510(k) K033146

Substantially Equivalent

Tra & Accessories

FDA 510(k) clearance K033146 for TONO-PEN TONOMETER TIP COVER, Substantially Equivalent on 2004-11-23. Applicant: Tra & Accessories. Device class: 2.

Clearance details

Applicant: Tra & Accessories
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2003-09-30
Decision date: 2004-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Dimas, CA, US

Download summary PDF View on FDA.gov ↗

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