FDA 510(k) Application Details - K991687

Device Classification Name Resin, Denture, Relining, Repairing, Rebasing

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510(K) Number K991687
Device Name Resin, Denture, Relining, Repairing, Rebasing
Applicant BOSWORTH CO.
7227 NORTH HAMLIN AVE.
SKOKIE, IL 60076-3999 US
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Contact MILDRED M GOLDSTEIN
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Regulation Number 872.3760

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Classification Product Code EBI
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Date Received 05/17/1999
Decision Date 10/07/1999
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



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