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FDA 510(k) Application Details - K070297
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K070297
Device Name
Handpiece, Air-Powered, Dental
Applicant
DENTAL AIR SOLUTIONS OF NC, INC.
224 BRANCHSIDE LANE
HOLLY SPRINGS, NC 27540 US
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Contact
THOMAS FEE
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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
01/31/2007
Decision Date
02/05/2007
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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