ULTRACISION HARMONIC SCALPEL HAND PIECE

Instrument, Ultrasonic Surgical

ETHICON ENDO-SURGERY, INC.

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

Pre-market Notification Details

Device IDK990430
510k NumberK990430
Device Name:ULTRACISION HARMONIC SCALPEL HAND PIECE
ClassificationInstrument, Ultrasonic Surgical
Applicant ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
ContactRuth Ann Wood
CorrespondentRuth Ann Wood
ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati,  OH  45242 -2839
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-11
Decision Date1999-03-12
Summary:summary

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