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FDA 510(k) Application Details - K001690
Device Classification Name
Needle, Hypodermic, Single Lumen
More FDA Info for this Device
510(K) Number
K001690
Device Name
Needle, Hypodermic, Single Lumen
Applicant
JOHNSON & JOHNSON MEDICAL, INC.
2500 ARBROOK BLVD.
P.O. BOX 90130
ARLINGTON, TX 76004-0130 US
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Contact
DORENE MARKWIESE
Other 510(k) Applications for this Contact
Regulation Number
880.5570
More FDA Info for this Regulation Number
Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
06/02/2000
Decision Date
07/31/2000
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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