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FDA 510(k)

PREMIUM

K-Number: K011130 · 2001-07-05

ApplicantHeraeus Kulzer, Inc.
Decision Date2001-07-05
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 2001-07-05 under 510(k) number K011130. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIUM?

PREMIUM is a medical device that received FDA 510(k) clearance on 2001-07-05. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K011130.

When did PREMIUM receive FDA 510(k) clearance?

PREMIUM received FDA 510(k) clearance on 2001-07-05, under 510(k) number K011130.

Who is the listed applicant for PREMIUM?

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

What is the FDA product code for PREMIUM?

The FDA product code for PREMIUM is ELM.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: ELM)

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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