FDA 510(k) Application Details - K973363

Device Classification Name Source, Isotope, Sealed, Gold, Titanium, Platinum

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510(K) Number K973363
Device Name Source, Isotope, Sealed, Gold, Titanium, Platinum
Applicant ML STRATEGIES, INC.
ONE FINANCIAL CENTER
BOSTON, MA 02111 US
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Contact ALLAN M GREEN
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Regulation Number 892.5730

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Classification Product Code IWI
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Date Received 09/08/1997
Decision Date 07/02/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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