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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, Accessories
510(k) Number K150532
Device Name Universal Light Handle Cover, Light Handle Cover
Applicant
Key Surgical, Inc.
8101 Wallace Road
Eden Prairie,  MN  55344
Applicant Contact Amy Yanta
Correspondent
Key Surgical, Inc.
8101 Wallace Road
Eden Prairie,  MN  55344
Correspondent Contact Amy Yanta
Regulation Number878.4580
Classification Product Code
FTA  
Date Received03/02/2015
Decision Date 09/22/2015
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
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