I-125 RAPID STRAND, MODEL 7000— 510(k) K030594

Substantially Equivalent

Amersham Health

FDA 510(k) clearance K030594 for I-125 RAPID STRAND, MODEL 7000, Substantially Equivalent on 2003-04-10. Applicant: Amersham Health. Device class: 2.

Clearance details

Applicant: Amersham Health
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2003-02-25
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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