FDA 510(k) Application Details - K071473

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K071473
Device Name Bronchoscope (Flexible Or Rigid)
Applicant SUPERDIMENSION, LTD.
555 ZANG STREET
SUITE 100
LAKEWOOD, CO 80228 US
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Contact CLAY ANSELMO
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 05/29/2007
Decision Date 07/12/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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