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FDA 510(k) Application Details - K083101
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K083101
Device Name
Handpiece, Air-Powered, Dental
Applicant
SABLE INDUSTRIES, INC.
16576 W. 53rd way
Golden, CO 80403 US
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Contact
KEVIN RANDALL
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
10/20/2008
Decision Date
02/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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