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FDA 510(k) Application Details - K012308
Device Classification Name
Handpiece, Air-Powered, Dental
More FDA Info for this Device
510(K) Number
K012308
Device Name
Handpiece, Air-Powered, Dental
Applicant
KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH, IL 60047 US
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Contact
JOHN WESTERMEIER
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
07/23/2001
Decision Date
06/26/2002
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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