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FDA 510(k) Application Details - K101551
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K101551
Device Name
Handpiece, Air-Powered, Dental
Applicant
DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD.
3500 SOUTH DUPONT HIGHWAY
DOVER, DE 19901 US
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Contact
LEON LU
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
06/04/2010
Decision Date
09/09/2010
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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