FDA 510(k) Application Details - K960051

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K960051
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant NISSHO CORP.
1384 COPPERFIELD COURT
LEXINGTON, KY 40514-1268 US
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Contact LUIS CANDELARIO
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 01/04/1996
Decision Date 03/28/1996
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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