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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K992760
Device Name SELECT-SUTTER MICRO BIPOLAR FORCEPS
Applicant
Select Medizintechnik Hermann Sutter GmbH
9070 Bluffview Trace
Roswell,  GA  30076
Applicant Contact ANITA THIBEAULT
Correspondent
Select Medizintechnik Hermann Sutter GmbH
9070 Bluffview Trace
Roswell,  GA  30076
Correspondent Contact ANITA THIBEAULT
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/17/1999
Decision Date 10/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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