Who is the manufacturer of E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

E-Z-Em, Inc. filed the 510(k) submission for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS (K841720).

What is the FDA product code for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

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

What is the regulatory pathway for E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

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

Who can help prepare an FDA 510(k) submission like E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS?

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 PERCUTANEOUS NEPHROSTOMY SETS

K841720 · E-Z-Em, Inc. · LJE · Jul 26, 1984 · GU

Device Facts

Record ID	K841720
Device Name	E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
Applicant	E-Z-Em, Inc.
Product Code	LJE · GU
Decision Date	Jul 26, 1984
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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