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FDA 510(k) Application Details - K080240
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K080240
Device Name
Handpiece, Air-Powered, Dental
Applicant
PROMIDENT LLC
242 NORTH MAIN ST.
NEW CITY, NY 10956 US
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Contact
GARY KRIS
Other 510(k) Applications for this Contact
Regulation Number
872.4200
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Classification Product Code
EFB
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More FDA Info for this Product Code
Date Received
01/31/2008
Decision Date
02/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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