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FDA 510(k)

ALASTIGARD

K-Number: K890529 · 1989-03-09

ApplicantUnitek Corp.
Decision Date1989-03-09
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALASTIGARD is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1989-03-09 under 510(k) number K890529. 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 ALASTIGARD?

ALASTIGARD is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is Unitek Corp.. The 510(k) number is K890529.

When did ALASTIGARD receive FDA 510(k) clearance?

ALASTIGARD received FDA 510(k) clearance on 1989-03-09, under 510(k) number K890529.

Who is the listed applicant for ALASTIGARD?

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

What is the FDA product code for ALASTIGARD?

The FDA product code for ALASTIGARD is EJF.

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.

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Other records listing Unitek Corp. 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.

K944286METAL-LINED TRANSCEND CERAMIC BRACKETK933501ALASTIKK940165ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENT

View all 23 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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