FDA 510(k) Application Details - K023868

Device Classification Name Rongeur, Manual

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510(K) Number K023868
Device Name Rongeur, Manual
Applicant DANNORITZER MEDICAL INSTRUMENTS
271 WALDROUP RD.
P.O. BOX 457
HOT SPRINGS, NC 28783 US
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Contact DAGMAR S MASER
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Regulation Number 882.4840

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Classification Product Code HAE
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Date Received 11/20/2002
Decision Date 02/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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