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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 K993054
Device Name ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact RUTH ANN WOOD
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact RUTH ANN WOOD
Classification Product Code
LFL  
Date Received09/13/1999
Decision Date 12/09/1999
Decision Substantially Equivalent (SESE)
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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