FDA 510(k) Application Details - K980159

Device Classification Name Cement, Dental

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510(K) Number K980159
Device Name Cement, Dental
Applicant CLOSURE MEDICAL CORP.
5265 CAPITAL BLVD.
RALEIGH, NC 27616 US
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Contact JOE B BAREFOOT
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 01/16/1998
Decision Date 04/09/1998
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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