Who is the manufacturer of CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR?

Valleylab, Inc. filed the 510(k) submission for CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR (K910696).

What is the FDA product code for CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR?

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

What is the regulatory pathway for CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR?

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

Who can help prepare an FDA 510(k) submission like CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA 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.

CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR

K910696 · Valleylab, Inc. · LFL · Jun 11, 1991 · SU

Device Facts

Record ID	K910696
Device Name	CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
Applicant	Valleylab, Inc.
Product Code	LFL · SU
Decision Date	Jun 11, 1991
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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