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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 K873786
Device Name SMITH & NEPHEW DAYLIGHTER(TM)
Applicant
SMITH & NEPHEW, INC.
1920 S. JEFFERSON AVE.
ST. LOUIS,  MO  63104
Applicant Contact KEVIN RANDICH
Correspondent
SMITH & NEPHEW, INC.
1920 S. JEFFERSON AVE.
ST. LOUIS,  MO  63104
Correspondent Contact KEVIN RANDICH
Regulation Number878.4580
Classification Product Code
FSY  
Date Received09/17/1987
Decision Date 10/23/1987
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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