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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 K160554
Device Name Enseal X1 Large Jaw Tissue Sealer
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD
CINCINNATI,  OH  45242
Applicant Contact DAVID LOCKE
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD
CINCINNATI,  OH  45242
Correspondent Contact DAVID LOCKE
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
HGI   LFL  
Date Received02/29/2016
Decision Date 09/09/2016
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
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