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FDA 510(k) Application Details - K033225
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K033225
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact
TINA STEFFANIE-OAK
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
10/06/2003
Decision Date
10/16/2003
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
Y
Expedited Review
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