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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K000229
Device Name VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
Applicant
Videolabs, Inc.
2530 Pennsylvania Ave.
Saint Louis Park,  MN  55426
Applicant Contact FRANK B FREEDMAN
Correspondent
Videolabs, Inc.
2530 Pennsylvania Ave.
Saint Louis Park,  MN  55426
Correspondent Contact FRANK B FREEDMAN
Regulation Number876.1500
Classification Product Code
FCW  
Date Received01/27/2000
Decision Date 03/21/2000
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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