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FDA 510(k)

NEO-CARE LUMBER PUNCTURE KIT

K-Number: K970997 · 1997-05-22

ApplicantKlein-Baker Medical, Inc.
Decision Date1997-05-22
Product CodeMIA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEO-CARE LUMBER PUNCTURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Klein-Baker Medical, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K970997. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-CARE LUMBER PUNCTURE KIT?

NEO-CARE LUMBER PUNCTURE KIT is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Klein-Baker Medical, Inc.. The 510(k) number is K970997.

When did NEO-CARE LUMBER PUNCTURE KIT receive FDA 510(k) clearance?

NEO-CARE LUMBER PUNCTURE KIT received FDA 510(k) clearance on 1997-05-22, under 510(k) number K970997.

Who is the listed applicant for NEO-CARE LUMBER PUNCTURE KIT?

The FDA 510(k) record lists Klein-Baker Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEO-CARE LUMBER PUNCTURE KIT?

The FDA product code for NEO-CARE LUMBER PUNCTURE KIT is MIA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Klein-Baker Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972731NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SETK970434NEO-PICCK963972NEO-CARE DUAL LUMEN UMBILICAL CATHETERK963867NEO-CARE CATHETERIZATION TRAY

Related Devices (Code: MIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectorsSmiths Medical Asd, Inc.K051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837Epimed International, Inc.K983858SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLESSims Portex, Inc.K982269CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAAllegiance Healthcare Corp.K971645REGANES SPINAL NEEDLE (VARIOUS)Avid N.I.T., Inc.K961324GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLESGlobal Medical Prods, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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