OPTIDOS— 510(k) K010705

Substantially Equivalent

Ptw-New York Corp.

FDA 510(k) clearance K010705 for OPTIDOS, Substantially Equivalent on 2003-03-11. Applicant: Ptw-New York Corp.. Device class: 2.

Clearance details

Applicant: Ptw-New York Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2001-03-09
Decision date: 2003-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, 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.