FDA 510(k) Application Details - K993147

Device Classification Name Set, Administration, Intravascular

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510(K) Number K993147
Device Name Set, Administration, Intravascular
Applicant THE KIPP GROUP
930 WANAMAKER AVE.
ONTARIO, CA 91761 US
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Contact GARY WERSCHMIDT
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 09/21/1999
Decision Date 11/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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