FDA 510(k) Application Details - K993848

Device Classification Name Set, Administration, Intravascular

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510(K) Number K993848
Device Name Set, Administration, Intravascular
Applicant MILLENNIUM MEDICAL DISTRIBUTION, INC.
1205 DE LA VINA
SANTA BARBARA, CA 93101 US
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Contact CHRISTINE EMANUEL
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 11/12/1999
Decision Date 01/27/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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