OPHTEC ENCLAVATION NEEDLE— 510(k) K030471

Substantially Equivalent

Ophtec, USA

FDA 510(k) clearance K030471 for OPHTEC ENCLAVATION NEEDLE, Substantially Equivalent on 2003-04-17. Applicant: Ophtec, USA. Device class: 1.

Clearance details

Applicant: Ophtec, USA
Product code: Code HNQ
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 2003-02-12
Decision date: 2003-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.