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FDA 510(k)

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT

K-Number: K964783 · 1997-02-12

ApplicantAlexander Medical, Inc.
Decision Date1997-02-12
Product CodeCAZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Alexander Medical, Inc.. It received FDA 510(k) clearance on 1997-02-12 under 510(k) number K964783. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT?

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Alexander Medical, Inc.. The 510(k) number is K964783.

When did EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT receive FDA 510(k) clearance?

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT received FDA 510(k) clearance on 1997-02-12, under 510(k) number K964783.

Who is the listed applicant for EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT?

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

What is the FDA product code for EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT?

The FDA product code for EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT is CAZ.

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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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