FDA 510(k) Application Details - K090055

Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental

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510(K) Number K090055
Device Name Handpiece, Belt And/Or Gear Driven, Dental
Applicant DPM USA CORP.
1460 NW 107 AVE. SUITE G
MIAMI, FL 33172 US
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Contact GEORGE ECHEVERRI
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Regulation Number 872.4200

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Classification Product Code EFA
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Date Received 01/08/2009
Decision Date 10/27/2009
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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