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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 K200841
Device Name Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11
Applicant
Ethicon Endo-Surgery, Llc
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Correspondent
Ethicon Endo-Surgery, Inc
4545 Creek Rd
Cincinnati,  OH  45242
Correspondent Contact Brian Godwin
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
HGI   LFL  
Date Received03/31/2020
Decision Date 05/11/2020
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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