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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Fiber Optic
510(k) Number K961536
Device Name FLEXSCOPE
Applicant
Matrix Medica, Inc.
14055 Grand Ave.
Suite D
Burnsville,  MN  55337
Applicant Contact AMJAD AHMAD
Correspondent
Matrix Medica, Inc.
14055 Grand Ave.
Suite D
Burnsville,  MN  55337
Correspondent Contact AMJAD AHMAD
Regulation Number876.1500
Classification Product Code
GDB  
Date Received04/22/1996
Decision Date 09/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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