FDA 510(k) Application Details - K070591

Device Classification Name Denture, Plastic, Teeth

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510(K) Number K070591
Device Name Denture, Plastic, Teeth
Applicant UNION DENTAL S.A./UNIDESA.ODI
PASEO DE LA ESTACION, 4
TIELMES, MADRID 28550 ES
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Contact JOSE LUIS RODRIGUEZ
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Regulation Number 872.3590

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Classification Product Code ELM
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Date Received 03/01/2007
Decision Date 05/11/2007
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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