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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
510(k) Number K911699
Device Name STI TISSUE MANIPULATOR
Applicant
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Applicant Contact ALAN T BECKMAN
Correspondent
Surgical Technologies, Inc.
750 Goddard Ave.
Chesterfield,  MO  63005
Correspondent Contact ALAN T BECKMAN
Regulation Number884.4150
Classification Product Code
HIN  
Date Received04/16/1991
Decision Date 06/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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