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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
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