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FDA 510(k) Application Details - K011860
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K011860
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
KEYSTONE MEDICAL
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact
ALAN P SCHWARTZ
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Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
06/14/2001
Decision Date
06/27/2001
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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