Empty I.V. Container

FDA 510(k) K910936 · Ellis Pharmaceutical Consulting, Inc.

Substantially Equivalent

510(k) numberK910936

Submission

Device name
Empty I.V. Container
Applicant
Ellis Pharmaceutical Consulting, Inc.
Princeton, NJ, US
Received
March 6, 1991
Decision date
July 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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Questions and answers

When was Empty I.V. Container cleared by the FDA?

Empty I.V. Container (K910936) received a 510(k) decision of Substantially Equivalent on July 16, 1991, 132 days after the submission was received.

What is the product code of K910936?

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