Who is the manufacturer of E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

E-Z-Em, Inc. filed the 510(k) submission for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE (K842121).

What is the FDA product code for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

LJE. as a Class U device in the GU panel.

What is the regulatory pathway for E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

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

Who can help prepare an FDA 510(k) submission like E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE?

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.

E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE

K842121 · E-Z-Em, Inc. · LJE · Oct 1, 1984 · GU

Device Facts

Record ID	K842121
Device Name	E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
Applicant	E-Z-Em, Inc.
Product Code	LJE · GU
Decision Date	Oct 1, 1984
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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