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FDA 510(k) Application Details - K980493
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K980493
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON, TX 76004-0130 US
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Contact
LINDA G HILL
Other 510(k) Applications for this Contact
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
02/09/1998
Decision Date
04/28/1998
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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