Who is the manufacturer of COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST?

Lacrimedics, Inc. filed the 510(k) submission for COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (K895342).

What is the FDA product code for COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST?

LZU. as a Class U device in the OP panel.

What is the regulatory pathway for COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST?

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

Who can help prepare an FDA 510(k) submission like COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST?

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.

COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST

K895342 · Lacrimedics, Inc. · LZU · Nov 2, 1989 · OP

Device Facts

Record ID	K895342
Device Name	COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
Applicant	Lacrimedics, Inc.
Product Code	LZU · OP
Decision Date	Nov 2, 1989
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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