FDA 510(k) Application Details - K020544

Device Classification Name Set, Administration, Intravascular

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510(K) Number K020544
Device Name Set, Administration, Intravascular
Applicant CHURCHILL MEDICAL SYSTEMS, INC.
87 VENTURE DR.
DOVER, NH 03820 US
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Contact KEITH PALUCH
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 02/15/2002
Decision Date 03/12/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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