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FDA 510(k)

T-IV ELITE ALLOY

K-Number: K820530 · 1982-03-19

ApplicantHowmedica Corp.
Decision Date1982-03-19
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T-IV ELITE ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1982-03-19 under 510(k) number K820530. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-IV ELITE ALLOY?

T-IV ELITE ALLOY is a medical device that received FDA 510(k) clearance on 1982-03-19. The listed applicant is Howmedica Corp.. The 510(k) number is K820530.

When did T-IV ELITE ALLOY receive FDA 510(k) clearance?

T-IV ELITE ALLOY received FDA 510(k) clearance on 1982-03-19, under 510(k) number K820530.

Who is the listed applicant for T-IV ELITE ALLOY?

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

What is the FDA product code for T-IV ELITE ALLOY?

The FDA product code for T-IV ELITE ALLOY is EJS.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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