Empty, Solution Transfer Container with Detatchable Leg Set

FDA 510(k) K941731 · Incutech, Inc.

Substantially Equivalent

510(k) numberK941731

Submission

Device name
Empty, Solution Transfer Container with Detatchable Leg Set
Applicant
Incutech, Inc.
Greensboro, NC, US
Received
April 7, 1994
Decision date
July 22, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KPE – Container, I.V.
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5025
Specialty
General Hospital

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More from Gilero, LLC

510(k)DeviceDecision
K960619More-L Injector Kit PlusCAZ · Traditional 06/20/1996SE
K951870Morell InjectorCAZ · Traditional 01/22/1996SESK
K942394Safe Vent SystemFMF · Traditional 01/27/1995SE
K940258Solution Transfer Container W/Attached Leg Set (Empty)KPE · Traditional 03/28/1994SE

Questions and answers

When was Empty, Solution Transfer Container with Detatchable Leg Set cleared by the FDA?

Empty, Solution Transfer Container with Detatchable Leg Set (K941731) received a 510(k) decision of Substantially Equivalent on July 22, 1994, 106 days after the submission was received.

What is the product code of K941731?

The FDA product code is KPE – Container, I.V., a Class II (moderate risk) device regulated under 21 CFR 880.5025.