RE-ENTRANT CHAMBER— 510(k) K013689

Substantially Equivalent

Sun Nuclear Corp.

FDA 510(k) clearance K013689 for RE-ENTRANT CHAMBER, Substantially Equivalent on 2002-07-02. Applicant: Sun Nuclear Corp.. Device class: 2.

Clearance details

Applicant: Sun Nuclear Corp.
Product code: Code KPT
Device class: Class 2
Regulation: 21 CFR 892.1360
Advisory panel: Radiology
Date received: 2001-11-06
Decision date: 2002-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, 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.