FDA 510(k) Application Details - K102241

Device Classification Name Controller, Foot, Handpiece And Cord

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510(K) Number K102241
Device Name Controller, Foot, Handpiece And Cord
Applicant ANTHOGYR SAS
2237, AVENUE ANDRE LASQUIN
SALLANCHES 74700 FR
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Contact BRAYETTE SABINE
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Regulation Number 872.4200

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Classification Product Code EBW
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Date Received 08/09/2010
Decision Date 03/23/2011
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



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