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FDA 510(k) Application Details - K983974
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K983974
Device Name
Syringe, Piston
Applicant
Owen Mumford USA, Inc.
849 PICKENS INDUSTRIAL DR.
SUITE 14
MARIETTA, GA 30062 US
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Contact
ROBERT SHAW
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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
11/09/1998
Decision Date
12/21/1998
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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