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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, ultrasonic surgical
510(k) Number K191555
Device Name HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Ethicon Endo-Surgery, Inc.
4545 Creek Road, ML39
Cincinnati,  OH  45242
Correspondent Contact Brian Godwin
Classification Product Code
Date Received06/12/2019
Decision Date 02/28/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls