FDA 510(k) Application Details - K150280

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K150280
Device Name Bronchoscope (Flexible Or Rigid)
Applicant SANOVAS, INC.
2597 Kerner Blvd
San Rafael, CA 94901 US
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Contact Roy Morgan
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 02/05/2015
Decision Date 06/11/2015
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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