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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Electrical
510(k) Number K850168
Device Name STILLE SCANDIA OPERATING TABLES RC 3000,1100
Applicant
Stille-Werner (Usa), Inc.
200 Thirteenth Ave.
Ronkonkoma,  NY  11779
Applicant Contact ROBERT W O'DONNELL
Correspondent
Stille-Werner (Usa), Inc.
200 Thirteenth Ave.
Ronkonkoma,  NY  11779
Correspondent Contact ROBERT W O'DONNELL
Regulation Number878.4960
Classification Product Code
GDC  
Date Received01/16/1985
Decision Date 03/28/1985
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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