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FDA 510(k)

P2 POLYETHER

K-Number: K030318 · 2003-04-03

ApplicantHeraeus Kulzer, Inc.
Decision Date2003-04-03
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

P2 POLYETHER 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 2003-04-03 under 510(k) number K030318. 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 P2 POLYETHER?

P2 POLYETHER is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K030318.

When did P2 POLYETHER receive FDA 510(k) clearance?

P2 POLYETHER received FDA 510(k) clearance on 2003-04-03, under 510(k) number K030318.

Who is the listed applicant for P2 POLYETHER?

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 P2 POLYETHER?

The FDA product code for P2 POLYETHER is ELW.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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