FDA 510(k) Application Details - K971732

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K971732
Device Name Handpiece, Air-Powered, Dental
Applicant PAULINE M. NICHOLLS
321 SOUTH BROAD ST.
MONROE, GA 30655 US
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Contact PAULINE M NICHOLLS
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 05/09/1997
Decision Date 01/11/2000
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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