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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 K904965
Device Name SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
Applicant
Smith & Nephew Equipment Group
1920 A. Jefferson Ave.
St. Louis,  MO  63104
Applicant Contact KEVIN RANDICH
Correspondent
Smith & Nephew Equipment Group
1920 A. Jefferson Ave.
St. Louis,  MO  63104
Correspondent Contact KEVIN RANDICH
Regulation Number878.4580
Classification Product Code
FSY  
Date Received11/05/1990
Decision Date 01/16/1991
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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