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FDA 510(k) Application Details - K073353
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K073353
Device Name
Handpiece, Air-Powered, Dental
Applicant
PRODRIVE SYSTEMS, INC.
812 COMMERCE DR.
OGDENSBURG, NY 13669 US
Other 510(k) Applications for this Company
Contact
TIMOTHY F NASON
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
11/29/2007
Decision Date
12/07/2007
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
Y
Expedited Review
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