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FDA 510(k)

PREVISION CHEM

K-Number: K010541 · 2001-07-31

ApplicantHeraeus Kulzer, Inc.
Decision Date2001-07-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREVISION CHEM 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 2001-07-31 under 510(k) number K010541. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREVISION CHEM?

PREVISION CHEM is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K010541.

When did PREVISION CHEM receive FDA 510(k) clearance?

PREVISION CHEM received FDA 510(k) clearance on 2001-07-31, under 510(k) number K010541.

Who is the listed applicant for PREVISION CHEM?

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 PREVISION CHEM?

The FDA product code for PREVISION CHEM is EMA.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: EMA)

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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