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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K132747
Device Name VISUM BLADE LED SURGICAL LIGHTING SYSTEM
Applicant
Stryker Communications
1410 Lakeside Pkwy. #100
Flower Mound,  TX  75028
Applicant Contact TREY THORSEN
Correspondent
Stryker Communications
1410 Lakeside Pkwy. #100
Flower Mound,  TX  75028
Correspondent Contact TREY THORSEN
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/03/2013
Decision Date 12/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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