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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiologic
510(k) Number K860620
Device Name SHAMPAINE RADI-OP MODEL 1700RC
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 Number892.1980
Classification Product Code
KXJ  
Date Received02/19/1986
Decision Date 04/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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