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FDA 510(k)

SOWELL COBALT-CHROME METAL ALLOY

K-Number: K973567 · 1997-12-11

ApplicantC.K. International Trading
Decision Date1997-12-11
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOWELL COBALT-CHROME METAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is C.K. International Trading. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K973567. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOWELL COBALT-CHROME METAL ALLOY?

SOWELL COBALT-CHROME METAL ALLOY is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is C.K. International Trading. The 510(k) number is K973567.

When did SOWELL COBALT-CHROME METAL ALLOY receive FDA 510(k) clearance?

SOWELL COBALT-CHROME METAL ALLOY received FDA 510(k) clearance on 1997-12-11, under 510(k) number K973567.

Who is the listed applicant for SOWELL COBALT-CHROME METAL ALLOY?

The FDA 510(k) record lists C.K. International Trading as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOWELL COBALT-CHROME METAL ALLOY?

The FDA product code for SOWELL COBALT-CHROME METAL ALLOY is EJH.

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 C.K. International Trading 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.

K973569SOWELL NICKEL-CHROME-MOLYBDENUM ALLOYK973568SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOYK973566SOWELL PATENTED NON-PRECIOUS METAL ALLOY

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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