FDA 510(k) Application Details - K010373

Device Classification Name Set, Administration, Intravascular

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510(K) Number K010373
Device Name Set, Administration, Intravascular
Applicant STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA, MN 55391 US
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Contact JOEL DOUGLASS
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 02/07/2001
Decision Date 03/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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