FDA 510(k) Application Details - K961536

Device Classification Name Endoscope, Fiber Optic

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510(K) Number K961536
Device Name Endoscope, Fiber Optic
Applicant MATRIX MEDICA, INC.
14055 GRAND AVE.
SUITE D
BURNSVILLE, MN 55337 US
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Contact AMJAD AHMAD
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Regulation Number 876.1500

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Classification Product Code GDB
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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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