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FDA 510(k)

FREEDLAND TENSION SYSTEM

K-Number: K003648 · 2001-02-23

ApplicantEtzem Technologies, Inc.
Decision Date2001-02-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FREEDLAND TENSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etzem Technologies, Inc.. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K003648. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEDLAND TENSION SYSTEM?

FREEDLAND TENSION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-23. The listed applicant is Etzem Technologies, Inc.. The 510(k) number is K003648.

When did FREEDLAND TENSION SYSTEM receive FDA 510(k) clearance?

FREEDLAND TENSION SYSTEM received FDA 510(k) clearance on 2001-02-23, under 510(k) number K003648.

Who is the listed applicant for FREEDLAND TENSION SYSTEM?

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

What is the FDA product code for FREEDLAND TENSION SYSTEM?

The FDA product code for FREEDLAND TENSION SYSTEM is MBI.

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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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