FDA 510(k) Application Details - K972935

Device Classification Name Cement, Dental

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510(K) Number K972935
Device Name Cement, Dental
Applicant S.S. WHITE MFG., LTD.
9, MADLEAZE ESTATE, BRISTOL RD
GLOUCESTER GL1 5SG GB
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Contact HUGH SAVELL
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 08/08/1997
Decision Date 01/29/1998
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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