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FDA 510(k) Application Details - K024165
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K024165
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
BISTECH, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact
PAMELA PAPINEAU
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
12/17/2002
Decision Date
01/10/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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