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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Illuminator, Fiberoptic, Surgical Field
510(k) Number K882956
Device Name VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
Applicant
Vital Metrics, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Applicant Contact JOHN B DUBECK
Correspondent
Vital Metrics, Inc.
1150 17th St., NW
Suite 1000
Washington,  DC  20036
Correspondent Contact JOHN B DUBECK
Regulation Number878.4580
Classification Product Code
HBI  
Date Received07/13/1988
Decision Date 08/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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