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FDA 510(k)

PROVIL NOVO

K-Number: K973694 · 1997-11-24

ApplicantHeraeus Kulzer, Inc.
Decision Date1997-11-24
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROVIL NOVO 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 1997-11-24 under 510(k) number K973694. 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 PROVIL NOVO?

PROVIL NOVO is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K973694.

When did PROVIL NOVO receive FDA 510(k) clearance?

PROVIL NOVO received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973694.

Who is the listed applicant for PROVIL NOVO?

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 PROVIL NOVO?

The FDA product code for PROVIL NOVO is ELW.

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Other records listing Heraeus Kulzer, 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.

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Related Devices (Code: ELW)

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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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