FDA 510(k) Application Details - K031851

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K031851
Device Name Handpiece, Air-Powered, Dental
Applicant BETHEL, INC
320 S. VINE AVENUE
TYLER, TX 75702 US
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Contact ERIC WADE
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 06/16/2003
Decision Date 08/01/2003
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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