NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A— 510(k) K972271

Name: FDA 510(k) clearance K972271
Creator: U.S. Food and Drug Administration
Published: 1997-10-28

Substantially Equivalent

Ml Strategies, Inc.

FDA 510(k) clearance K972271 for NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A, Substantially Equivalent on 1997-10-28. Applicant: Ml Strategies, Inc.. Device class: 2.

Clearance details

Applicant: Ml Strategies, Inc.
Product code: Code KXK
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1997-06-18
Decision date: 1997-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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