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FDA 510(k) Application Details - K990020
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K990020
Device Name
Syringe, Piston
Applicant
TE ME NA S.A.R.L.
21981 U.S. 19N
CLEARWATER, FL 33765 US
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Contact
DONALD F RYAN
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
01/04/1999
Decision Date
06/24/1999
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
N
Expedited Review
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