Ican GT Drainage Bag

FDA 510(k) K914530 · Icn Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK914530

Submission

Device name
Ican GT Drainage Bag
Applicant
Icn Pharmaceuticals, Inc.
Costa Mesa, CA, US
Received
October 11, 1991
Decision date
December 18, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FRQ – Tube, Levine
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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Questions and answers

When was Ican GT Drainage Bag cleared by the FDA?

Ican GT Drainage Bag (K914530) received a 510(k) decision of Substantially Equivalent on December 18, 1991, 68 days after the submission was received.

What is the product code of K914530?

The FDA product code is FRQ – Tube, Levine, a Class II (moderate risk) device regulated under 21 CFR 876.5980.