Who is the manufacturer of SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

Sharplan Lasers, Inc. filed the 510(k) submission for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS (K883091).

What is the FDA product code for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

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

What is the regulatory pathway for SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

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

Who can help prepare an FDA 510(k) submission like SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS?

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.

SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS

K883091 · Sharplan Lasers, Inc. · LFL · Oct 14, 1988 · SU

Device Facts

Record ID	K883091
Device Name	SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
Applicant	Sharplan Lasers, Inc.
Product Code	LFL · SU
Decision Date	Oct 14, 1988
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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