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510(k) K972271

NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A by Ml Strategies, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1997
Date Received
June 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Ml Strategies, Inc.

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  • K950354 — HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNA (July 19, 1995)

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