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FDA 510(k) Application Details - K070001
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K070001
Device Name
Handpiece, Air-Powered, Dental
Applicant
MTI PRECISION PRODUCTS
175 OBERLIN AVE., NORTH
LAKEWOOD, NJ 08701 US
Other 510(k) Applications for this Company
Contact
TOD BRENNER
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
01/03/2007
Decision Date
02/02/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K070001
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