FDA 510(k) Application Details - K051952

Device Classification Name Cement, Dental

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510(K) Number K051952
Device Name Cement, Dental
Applicant SCIENTIFIC PHARMACEUTICALS, INC.
3221 PRODUCER WAY
POMONA, CA 91768-3916 US
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Contact JAN A ORLOWSKI
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 07/18/2005
Decision Date 09/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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