FDA 510(k) Application Details - K103467

Device Classification Name Nasopharyngoscope (Flexible Or Rigid)

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510(K) Number K103467
Device Name Nasopharyngoscope (Flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE.
EL SEGUNDO, CA 90245 US
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Contact SHIVEN GANDHI
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Regulation Number 874.4760

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Classification Product Code EOB
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Date Received 11/24/2010
Decision Date 06/28/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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