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FDA 510(k)

KROM-ALGINATE AND ALGINATE PLUS

K-Number: K000686 · 2000-05-25

ApplicantCavex Holland BV
Decision Date2000-05-25
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KROM-ALGINATE AND ALGINATE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Cavex Holland BV. It received FDA 510(k) clearance on 2000-05-25 under 510(k) number K000686. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KROM-ALGINATE AND ALGINATE PLUS?

KROM-ALGINATE AND ALGINATE PLUS is a medical device that received FDA 510(k) clearance on 2000-05-25. The listed applicant is Cavex Holland BV. The 510(k) number is K000686.

When did KROM-ALGINATE AND ALGINATE PLUS receive FDA 510(k) clearance?

KROM-ALGINATE AND ALGINATE PLUS received FDA 510(k) clearance on 2000-05-25, under 510(k) number K000686.

Who is the listed applicant for KROM-ALGINATE AND ALGINATE PLUS?

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

What is the FDA product code for KROM-ALGINATE AND ALGINATE PLUS?

The FDA product code for KROM-ALGINATE AND ALGINATE PLUS is ELW.

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Other records listing Cavex Holland BV 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.

K073539PROVISA CEMK072245EMULATE ADVANCEDK062400IMPRESSIX, COLORCHANGE ALGINATEK061267SIMULATE, COLOR CHANGE ALGINATEK052455IMPRESSIXK051207CAVEX ORTHOTRACE

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Related Devices (Code: ELW)

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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