FDA 510(k) Application Details - K102517

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K102517
Device Name Handpiece, Air-Powered, Dental
Applicant THUNDER TIGER CORP.
NO. 7, 6TH ROAD
INDUSTRY PARK
TAICHUNG 40755 TW
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Contact JO LEE
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 09/02/2010
Decision Date 04/27/2011
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

FDA Source Information for K102517


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