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FDA 510(k) Application Details - K992802
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K992802
Device Name
Syringe, Piston
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON, MD 21921 US
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Contact
KRISTINE WAGNER
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
FMF
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More FDA Info for this Product Code
Date Received
08/19/1999
Decision Date
09/09/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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