FDA 510(k) Application Details - K011200

Device Classification Name Cement, Dental

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510(K) Number K011200
Device Name Cement, Dental
Applicant 3M COMPANY
3M CENTER, BLDG. 260-2B-12
ST PAUL, MN 55144 US
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Contact KAREN O'MALLEY
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 04/19/2001
Decision Date 06/14/2001
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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