FDA 510(k) Application Details - K984369

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K984369
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact KEVIN KENNAN
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 12/07/1998
Decision Date 01/29/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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