Klein Surgical Infiltration Pump, Model Kip-Ii

Q: What is the product code of K031432?

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

FDA 510(k) K031432 · Hk Surgical, Inc.

Substantially Equivalent

510(k) numberK031432

Submission

Device name: Klein Surgical Infiltration Pump, Model Kip-Ii
Applicant: Hk Surgical, Inc.
Oceanside, CA, US
Received: May 6, 2003
Decision date: August 7, 2003
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) statement 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 Surgical Infiltration Pump, Model Kip-Ii cleared by the FDA?

Klein Surgical Infiltration Pump, Model Kip-Ii (K031432) received a 510(k) decision of Substantially Equivalent on August 7, 2003, 93 days after the submission was received.

What is the product code of K031432?

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