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FDA 510(k)

CHANNEL-EDGE BRACKET SYSTEM

K-Number: K930881 · 1994-01-21

ApplicantDualtek, Inc.
Decision Date1994-01-21
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHANNEL-EDGE BRACKET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dualtek, Inc.. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K930881. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHANNEL-EDGE BRACKET SYSTEM?

CHANNEL-EDGE BRACKET SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Dualtek, Inc.. The 510(k) number is K930881.

When did CHANNEL-EDGE BRACKET SYSTEM receive FDA 510(k) clearance?

CHANNEL-EDGE BRACKET SYSTEM received FDA 510(k) clearance on 1994-01-21, under 510(k) number K930881.

Who is the listed applicant for CHANNEL-EDGE BRACKET SYSTEM?

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

What is the FDA product code for CHANNEL-EDGE BRACKET SYSTEM?

The FDA product code for CHANNEL-EDGE BRACKET SYSTEM is EJF.

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Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, 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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