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FDA 510(k) Application Details - K071965
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K071965
Device Name
Handpiece, Air-Powered, Dental
Applicant
SATELEC
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
Other 510(k) Applications for this Company
Contact
STEVE SALESKY
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2007
Decision Date
09/10/2007
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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