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FDA 510(k)

ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S

K-Number: K001418 · 2000-07-05

ApplicantProcera Sandvik, Inc.
Decision Date2000-07-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S is the device name listed in this FDA 510(k) record. The listed applicant is Procera Sandvik, Inc.. It received FDA 510(k) clearance on 2000-07-05 under 510(k) number K001418. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S?

ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S is a medical device that received FDA 510(k) clearance on 2000-07-05. The listed applicant is Procera Sandvik, Inc.. The 510(k) number is K001418.

When did ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S receive FDA 510(k) clearance?

ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S received FDA 510(k) clearance on 2000-07-05, under 510(k) number K001418.

Who is the listed applicant for ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S?

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

What is the FDA product code for ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S?

The FDA product code for ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S is EIH.

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Other records listing Procera Sandvik, Inc. 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.

K010630Y-TZP POWDER AND PROCERA ALLZIRKON

Related Devices (Code: EIH)

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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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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