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FDA 510(k)

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM

K-Number: K904380 · 1993-04-08

ApplicantCustom Medical Concepts, Inc.
Decision Date1993-04-08
Product CodeMIA
Advisory CommitteeAN
DecisionUnknown

Device Summary

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical Concepts, Inc.. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K904380. The device is classified under product code MIA. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM?

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Custom Medical Concepts, Inc.. The 510(k) number is K904380.

When did SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM receive FDA 510(k) clearance?

SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM received FDA 510(k) clearance on 1993-04-08, under 510(k) number K904380.

Who is the listed applicant for SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM?

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

What is the FDA product code for SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM?

The FDA product code for SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM is MIA.

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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.K970997NEO-CARE LUMBER PUNCTURE KITKlein-Baker Medical, 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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