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FDA 510(k) Application Details - K021344
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K021344
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
VISION-SCIENCES, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
Other 510(k) Applications for this Company
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
04/29/2002
Decision Date
05/24/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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