FDA 510(k) Application Details - K970827

Device Classification Name Alloy, Metal, Base

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510(K) Number K970827
Device Name Alloy, Metal, Base
Applicant ALLAN SCHULMAN,D.D.S., M.S.
138-40 78TH RD.
FLUSHING, NY 11367 US
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Contact ALLAN SCHULMAN
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Regulation Number 872.3710

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Classification Product Code EJH
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Date Received 03/06/1997
Decision Date 04/16/1997
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

FDA Source Information for K970827


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