FDA 510(k) Application Details - K981234

Device Classification Name Handle, Instrument, Dental

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510(K) Number K981234
Device Name Handle, Instrument, Dental
Applicant LONE STAR TECHNOLOGIES
31 RUNNYMEADE
CHATHAM, NJ 07928 US
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Contact EDWARD SPEHAR
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Regulation Number 872.4565

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Classification Product Code EJB
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Date Received 04/04/1998
Decision Date 06/05/1998
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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