FDA 510(k) Application Details - K983625

Device Classification Name Unit, Operative Dental

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510(K) Number K983625
Device Name Unit, Operative Dental
Applicant SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE 13011 FR
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Contact PIERRE MONTILLOT
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 10/15/1998
Decision Date 01/11/1999
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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