FDA 510(k) Application Details - K964863

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K964863
Device Name Controller, Foot, Handpiece And Cord
Applicant BELL INTL., INC.
31 EDWARDS CT.
BURLINGAME, CA 94010 US
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Contact DEWEY BELL
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Regulation Number 872.4200

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Classification Product Code EBW
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Date Received 12/04/1996
Decision Date 02/28/1997
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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