FDA 510(k) Application Details - K954797

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K954797
Device Name Bronchoscope (Flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact RENATE A MACLAREN
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 10/18/1995
Decision Date 01/17/1996
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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