Question 1

Who is the manufacturer of MANAN UNIVERSAL SUMP DRAINAGE CATHETER?

Accepted Answer

Manan Medical Products, Inc. submitted the Traditional clearance for MANAN UNIVERSAL SUMP DRAINAGE CATHETER (K953601).

Question 2

What is the FDA product code for MANAN UNIVERSAL SUMP DRAINAGE CATHETER?

Accepted Answer

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

Question 3

When was MANAN UNIVERSAL SUMP DRAINAGE CATHETER cleared by the FDA?

Accepted Answer

Mar 26, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for MANAN UNIVERSAL SUMP DRAINAGE CATHETER?

Accepted Answer

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

Record ID	K953601
Device Name	MANAN UNIVERSAL SUMP DRAINAGE CATHETER
Applicant	Manan Medical Products, Inc.
Product Code	LJE · GU
Decision Date	Mar 26, 1996
Decision	SESE
Submission Type	Traditional
Device Class	Class U

MANAN UNIVERSAL SUMP DRAINAGE CATHETER

Device Facts