FDA 510(k) Application Details - K974097

Device Classification Name Cement, Dental

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510(K) Number K974097
Device Name Cement, Dental
Applicant BLACKLOCK MEDICAL PRODUCTS, INC.
6671 LONDON COURT
DELTA V4K 4W7 CA
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Contact DON BLACKLOCK
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Regulation Number 872.3275

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Classification Product Code EMA
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Date Received 10/30/1997
Decision Date 04/09/1998
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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