FDA 510(k) Application Details - K960724

Device Classification Name Barrier, Synthetic, Intraoral

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510(K) Number K960724
Device Name Barrier, Synthetic, Intraoral
Applicant GEISTLICH-PHARMA
1050 CONNECTICUT AVE. N.W.
WASHINGTON, DC 20036 US
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Contact PETER S REICHERTZ
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Regulation Number 872.3930

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Classification Product Code NPK
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Date Received 02/22/1996
Decision Date 06/11/1997
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



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