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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K910783
Device Name SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
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 Number878.4950
Classification Product Code
BWN  
Date Received02/25/1991
Decision Date 04/02/1991
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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