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FDA 510(k) Application Details - K013006
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K013006
Device Name
Syringe, Antistick
Applicant
OVUS SYSTEMS
12300 TWINBROOK PKWY, STE 625
ROCKVILLE, MD 20852 US
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Contact
T. WHIT ATHEY
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
Date Received
09/06/2001
Decision Date
02/06/2002
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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