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FDA 510(k) Application Details - K063340
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K063340
Device Name
Syringe, Antistick
Applicant
SAFETY MEDICAL INTERNATIONAL, INCORPORATED
163 CABOT ST.
BEVERLY, MA 01915 US
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Contact
FRAN WHITE
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
11/06/2006
Decision Date
03/06/2007
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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