FDA 510(k) Application Details - K013129

Device Classification Name Material, Impression

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510(K) Number K013129
Device Name Material, Impression
Applicant RHODIA INC.
320 W. STANLEY AVE.
VENTURA, CA 93001 US
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Contact ALAIN MORIN
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 09/19/2001
Decision Date 10/10/2001
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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