Who is the manufacturer of SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

Mutoh America Co., Ltd. filed the 510(k) submission for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR (K010309).

What is the FDA product code for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

LFL. as a Class U device in the SU panel.

What is the regulatory pathway for SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR

K010309 · Mutoh America Co., Ltd. · LFL · Apr 18, 2001 · SU

Device Facts

Record ID	K010309
Device Name	SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
Applicant	Mutoh America Co., Ltd.
Product Code	LFL · SU
Decision Date	Apr 18, 2001
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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