FDA 510(k) Application Details - K974642

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K974642
Device Name Bronchoscope (Flexible Or Rigid)
Applicant PLASTIMED LABORATOIRE PHARMACEUTIQUE
212 3RD AVENUE NORTH
SUITE #446
MINNEAPOLIS, MN 55401 US
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Contact MIKE MCCORMICK
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 12/15/1997
Decision Date 03/13/1998
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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