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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 K970807
Device Name MOBILE OPERATING TABLE 1132.01
Applicant
Stierlen-Maquet AG
P.O. Box 2162
Rastatt,  DE 76411
Applicant Contact REINHARD PFEUFFER
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact CAROLE STAMP
Regulation Number878.4960
Classification Product Code
GDC  
Date Received03/05/1997
Decision Date 03/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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