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FDA 510(k) Application Details - K100833
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K100833
Device Name
Handpiece, Air-Powered, Dental
Applicant
OSSPRAY LTD
3116 N.W. 62ND TERRACE
GAINESVILLE, FL 32606 US
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Contact
DAVID GREENSPAN
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
03/24/2010
Decision Date
06/03/2010
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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