Who is the manufacturer of LORREX COVER SPONGES STERILE2'S AND NON-STERILE?

Lorrex Health Products filed the 510(k) submission for LORREX COVER SPONGES STERILE2'S AND NON-STERILE (K942070).

What is the FDA product code for LORREX COVER SPONGES STERILE2'S AND NON-STERILE?

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

What is the regulatory pathway for LORREX COVER SPONGES STERILE2'S AND NON-STERILE?

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

Who can help prepare an FDA 510(k) submission like LORREX COVER SPONGES STERILE2'S AND NON-STERILE?

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.

LORREX COVER SPONGES STERILE2'S AND NON-STERILE

K942070 · Lorrex Health Products · EFQ · May 19, 1994 · SU

Device Facts

Record ID	K942070
Device Name	LORREX COVER SPONGES STERILE2'S AND NON-STERILE
Applicant	Lorrex Health Products
Product Code	EFQ · SU
Decision Date	May 19, 1994
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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