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FDA 510(k)

IMPAX 5000

K-Number: K934386 · 1994-01-05

ApplicantHeraeus Kulzer, Inc.
Decision Date1994-01-05
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX 5000 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 1994-01-05 under 510(k) number K934386. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPAX 5000?

IMPAX 5000 is a medical device that received FDA 510(k) clearance on 1994-01-05. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K934386.

When did IMPAX 5000 receive FDA 510(k) clearance?

IMPAX 5000 received FDA 510(k) clearance on 1994-01-05, under 510(k) number K934386.

Who is the listed applicant for IMPAX 5000?

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 IMPAX 5000?

The FDA product code for IMPAX 5000 is LMD.

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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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: LMD)

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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