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FDA 510(k)

LORDEX LUMBAR EXTENSION MACHINE

K-Number: K930735 · 1994-09-29

ApplicantLordex, Inc.
Decision Date1994-09-29
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LORDEX LUMBAR EXTENSION MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Lordex, Inc.. It received FDA 510(k) clearance on 1994-09-29 under 510(k) number K930735. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORDEX LUMBAR EXTENSION MACHINE?

LORDEX LUMBAR EXTENSION MACHINE is a medical device that received FDA 510(k) clearance on 1994-09-29. The listed applicant is Lordex, Inc.. The 510(k) number is K930735.

When did LORDEX LUMBAR EXTENSION MACHINE receive FDA 510(k) clearance?

LORDEX LUMBAR EXTENSION MACHINE received FDA 510(k) clearance on 1994-09-29, under 510(k) number K930735.

Who is the listed applicant for LORDEX LUMBAR EXTENSION MACHINE?

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

What is the FDA product code for LORDEX LUMBAR EXTENSION MACHINE?

The FDA product code for LORDEX LUMBAR EXTENSION MACHINE is ISD.

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.

Related Devices (Code: ISD)

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.

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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