Neo-Care Lumber Puncture Kit

Q: What is the product code of K970997?

The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.

FDA 510(k) K970997 · Klein-Baker Medical, Inc.

Substantially Equivalent

510(k) numberK970997

Submission

Device name: Neo-Care Lumber Puncture Kit
Applicant: Klein-Baker Medical, Inc.
San Antonio, TX, US
Received: March 19, 1997
Decision date: May 22, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: MIA – Needle, Spinal, Short Term
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5150
Specialty: Anesthesiology

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K983858	Spinal Anesthesia Needles and Introducer NeedlesMIA · Traditional	Sims Portex, Inc.	01/29/1999SE
K982269	Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GAMIA · Traditional	Allegiance Healthcare Corp.	07/23/1998SE
K971645	Reganes Spinal Needle (Various)MIA · Traditional	Avid N.I.T., Inc.	08/01/1997SE
K961324	Global Medical Products Spinal,Conical Tip (Sprottle Style), Whitacre Style NeedlesMIA · Traditional	Global Medical Prods, Inc.	07/02/1996SE
K960405	Spinal NeedleMIA · Traditional	Promex, Inc.	02/28/1996SE
K942442	Acufex T-Fix Delivery SystemMIA · Traditional	Acufex Microsurgical, Inc.	12/05/1994SE
K904380	Spinal Cord Access Epidural Introducer SystemMIA · Traditional	Custom Medical Concepts, Inc.	04/08/1993SESK

More from Custom Medical Concepts, Inc.

510(k)	Device	Decision
K972731	Neo-Care Peritoneal Dialysis Administration SetKDJ · Traditional	09/29/1997SE
K970434	Neo-PiccLJS · Traditional	04/01/1997SE
K963972	Neo-Care Dual Lumen Umbilical CatheterFOS · Traditional	12/24/1996SE
K963867	Neo-Care Catheterization TrayFOZ · Traditional	11/06/1996SE

Questions and answers

When was Neo-Care Lumber Puncture Kit cleared by the FDA?

Neo-Care Lumber Puncture Kit (K970997) received a 510(k) decision of Substantially Equivalent on May 22, 1997, 64 days after the submission was received.

What is the product code of K970997?

The FDA product code is MIA – Needle, Spinal, Short Term, a Class II (moderate risk) device regulated under 21 CFR 868.5150.