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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Rigid
510(k) Number K844769
Device Name RIGID FIBEROPITC 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
Regulation Number876.1500
Classification Product Code
GCM  
Date Received12/07/1984
Decision Date 01/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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