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FDA 510(k)

CRANEX TOME CEPH, OR CRANEX TOME

K-Number: K974877 · 1998-03-27

ApplicantOrion Corporation Soredex
Decision Date1998-03-27
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRANEX TOME CEPH, OR CRANEX TOME is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corporation Soredex. It received FDA 510(k) clearance on 1998-03-27 under 510(k) number K974877. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANEX TOME CEPH, OR CRANEX TOME?

CRANEX TOME CEPH, OR CRANEX TOME is a medical device that received FDA 510(k) clearance on 1998-03-27. The listed applicant is Orion Corporation Soredex. The 510(k) number is K974877.

When did CRANEX TOME CEPH, OR CRANEX TOME receive FDA 510(k) clearance?

CRANEX TOME CEPH, OR CRANEX TOME received FDA 510(k) clearance on 1998-03-27, under 510(k) number K974877.

Who is the listed applicant for CRANEX TOME CEPH, OR CRANEX TOME?

The FDA 510(k) record lists Orion Corporation Soredex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANEX TOME CEPH, OR CRANEX TOME?

The FDA product code for CRANEX TOME CEPH, OR CRANEX TOME is EHD.

Related Clinical Trials

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Other records listing Orion Corporation Soredex 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.

K983267DIGORA FOR WINDOWS 2.0K934949DIGORAK880982ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

Related Devices (Code: EHD)

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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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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