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FDA 510(k)

HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY

K-Number: K875344 · 1988-03-18

ApplicantKulzer, Inc.
Decision Date1988-03-18
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, Inc.. It received FDA 510(k) clearance on 1988-03-18 under 510(k) number K875344. The device is classified under product code EJJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY?

HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY is a medical device that received FDA 510(k) clearance on 1988-03-18. The listed applicant is Kulzer, Inc.. The 510(k) number is K875344.

When did HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY receive FDA 510(k) clearance?

HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY received FDA 510(k) clearance on 1988-03-18, under 510(k) number K875344.

Who is the listed applicant for HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY?

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

What is the FDA product code for HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY?

The FDA product code for HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY is EJJ.

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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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