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FDA 510(k) Application Details - K092943
Device Classification Name
Syringe, Cartridge
More FDA Info for this Device
510(K) Number
K092943
Device Name
Syringe, Cartridge
Applicant
ARNOLD TUBER INDUSTRIES
97 MAIN STREET
HAMBURG, NY 14075 US
Other 510(k) Applications for this Company
Contact
MICHAEL TUBER
Other 510(k) Applications for this Contact
Regulation Number
872.6770
More FDA Info for this Regulation Number
Classification Product Code
EJI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2009
Decision Date
12/11/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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