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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850393
Device Name FLEXIBLE FIBEROPTIC ENDOSCOPE
Applicant
Microvasive
31 Maple St.
Milford,  MA  01757
Applicant Contact ALAN I WEST
Correspondent
Microvasive
31 Maple St.
Milford,  MA  01757
Correspondent Contact ALAN I WEST
Date Received02/01/1985
Decision Date 06/04/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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