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FDA 510(k) Application Details - K993526
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K993526
Device Name
Handpiece, Air-Powered, Dental
Applicant
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG, OR 97132-9257 US
Other 510(k) Applications for this Company
Contact
PATRICK RIDENOUR
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
10/18/1999
Decision Date
01/11/2000
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
N
Expedited Review
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