Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray

Instrument, Ultrasonic Surgical

Ethicon Endo-Surgery, LLC

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray.

Pre-market Notification Details

Device IDK211273
510k NumberK211273
Device Name:Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
ClassificationInstrument, Ultrasonic Surgical
Applicant Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo,  PR  00969
ContactNathan Anderson
CorrespondentRuth James
Ethicon Endo-Surgery, Inc. 4545 Creek Road Blue Ash,  OH  45242
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-27
Decision Date2021-05-21

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