FDA 510(k) Application Details - K970255

Device Classification Name Set, Administration, Intravascular

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510(K) Number K970255
Device Name Set, Administration, Intravascular
Applicant THE KIPP GROUP
930 WANAMAKER AVE.
ONTARIO, CA 91761 US
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Contact J EDWARD GUILMETTE
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/22/1997
Decision Date 04/14/1997
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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