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FDA 510(k) Application Details - K961536
Device Classification Name
Endoscope, Fiber Optic
More FDA Info for this Device
510(K) Number
K961536
Device Name
Endoscope, Fiber Optic
Applicant
MATRIX MEDICA, INC.
14055 GRAND AVE.
SUITE D
BURNSVILLE, MN 55337 US
Other 510(k) Applications for this Company
Contact
AMJAD AHMAD
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
GDB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/22/1996
Decision Date
09/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K961536
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