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FDA 510(k)

ALASTIK

K-Number: K940165 · 1994-03-07

ApplicantUnitek Corp.
Decision Date1994-03-07
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALASTIK is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K940165. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALASTIK?

ALASTIK is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Unitek Corp.. The 510(k) number is K940165.

When did ALASTIK receive FDA 510(k) clearance?

ALASTIK received FDA 510(k) clearance on 1994-03-07, under 510(k) number K940165.

Who is the listed applicant for ALASTIK?

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 ALASTIK?

The FDA product code for ALASTIK is ECI.

Related Clinical Trials

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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 BRACKETK933501ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENTK923432GERMAN MINI DYNALOCK

View all 23 devices →

Related Devices (Code: ECI)

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.

K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.K980053GLENROE CHAINGlenroe TechnologiesK973495GLENROE GLOW IN DARK ELASTOMERIC LIGATURESGlenroeK943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, 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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