Mednova Safety Bag

FDA 510(k) K853075 · Mednova Corp.

Substantially Equivalent

510(k) numberK853075

Submission

Device name
Mednova Safety Bag
Applicant
Mednova Corp.
New York, NY, US
Received
July 23, 1985
Decision date
October 16, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Mednova Safety Bag cleared by the FDA?

Mednova Safety Bag (K853075) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 85 days after the submission was received.

What is the product code of K853075?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.