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FDA 510(k) Application Details - K974642
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K974642
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
PLASTIMED LABORATOIRE PHARMACEUTIQUE
212 3RD AVENUE NORTH
SUITE #446
MINNEAPOLIS, MN 55401 US
Other 510(k) Applications for this Company
Contact
MIKE MCCORMICK
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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