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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Surgical And Accessories
510(k) Number K843806
Device Name VIS-1000 VIDEO SYSTEM
Applicant
Vistek Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Applicant Contact MARK R COLLINS
Correspondent
Vistek Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact MARK R COLLINS
Regulation Number878.4160
Classification Product Code
KQM  
Date Received09/27/1984
Decision Date 12/12/1984
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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