RE-ENTRANT CHAMBER, MODEL 1008 OR 44D— 510(k) K002446

Name: FDA 510(k) clearance K002446
Creator: U.S. Food and Drug Administration
Published: 2000-10-23

Substantially Equivalent

Sun Nuclear Corp.

FDA 510(k) clearance K002446 for RE-ENTRANT CHAMBER, MODEL 1008 OR 44D, Substantially Equivalent on 2000-10-23. Applicant: Sun Nuclear Corp.. Device class: 2.

Clearance details

Applicant: Sun Nuclear Corp.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2000-08-09
Decision date: 2000-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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