PROSTEC 125I BRANCHYTHERAPY SNAPSEED— 510(k) K001366

Name: FDA 510(k) clearance K001366
Creator: U.S. Food and Drug Administration
Published: 2000-09-19

Substantially Equivalent

Prostec, LLC

FDA 510(k) clearance K001366 for PROSTEC 125I BRANCHYTHERAPY SNAPSEED, Substantially Equivalent on 2000-09-19. Applicant: Prostec, LLC. Device class: 2.

Clearance details

Applicant: Prostec, LLC
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 2000-03-31
Decision date: 2000-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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