Klein Touch Pump and Disposable Tubing Set

FDA 510(k) K123822 · Hk Surgical, Inc.

Substantially Equivalent

510(k) numberK123822

Submission

Device name
Klein Touch Pump and Disposable Tubing Set
Applicant
Hk Surgical, Inc.
San Clemente, CA, US
Received
December 12, 2012
Decision date
September 27, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRN – Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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Questions and answers

When was Klein Touch Pump and Disposable Tubing Set cleared by the FDA?

Klein Touch Pump and Disposable Tubing Set (K123822) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 289 days after the submission was received.

What is the product code of K123822?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.