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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 K160103
Device Name Spetzler Malis Dual Illuminating Bipolar Forceps
Applicant
Synergetics
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Applicant Contact DAN REGAN
Correspondent
Synergetics
3845 Corporate Centre Dr.
O' Fallon,  MO  63368
Correspondent Contact DAN REGAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received01/19/2016
Decision Date 10/12/2016
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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