FDA 510(k) Application Details - K973961

Device Classification Name Cement, Dental

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510(K) Number K973961
Device Name Cement, Dental
Applicant 3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL, MN 55144-1000 US
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Contact LAEL J PICKETT
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 10/16/1997
Decision Date 12/17/1997
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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