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FDA 510(k) Application Details - K083454
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
More FDA Info for this Device
510(K) Number
K083454
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
U.S. SAFETY SYRINGES CO., INC.
1676 VILLAGE GREEN
CROFTON, MD 21114 US
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Contact
CHRISTINE SMITH
Other 510(k) Applications for this Contact
Regulation Number
880.5200
More FDA Info for this Regulation Number
Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
11/21/2008
Decision Date
12/04/2008
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
Y
Expedited Review
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