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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K982462
Device Name FIBER OPTIC ENDOILLUMINATION PROBE
Applicant
MICROVISION, INC.
34 FOLLY MILL RD.
SEABROOK,  NH  03874 -1651
Applicant Contact LEONARD KASTRILEVICH
Correspondent
MICROVISION, INC.
34 FOLLY MILL RD.
SEABROOK,  NH  03874 -1651
Correspondent Contact LEONARD KASTRILEVICH
Regulation Number876.1500
Classification Product Code
FFS  
Date Received07/15/1998
Decision Date 09/14/1998
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
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