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FDA 510(k)

AMALGAPHASE

K-Number: K921538 · 1992-08-10

ApplicantSaskan Amalgam Alloys, Inc.
Decision Date1992-08-10
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAPHASE is the device name listed in this FDA 510(k) record. The listed applicant is Saskan Amalgam Alloys, Inc.. It received FDA 510(k) clearance on 1992-08-10 under 510(k) number K921538. 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 AMALGAPHASE?

AMALGAPHASE is a medical device that received FDA 510(k) clearance on 1992-08-10. The listed applicant is Saskan Amalgam Alloys, Inc.. The 510(k) number is K921538.

When did AMALGAPHASE receive FDA 510(k) clearance?

AMALGAPHASE received FDA 510(k) clearance on 1992-08-10, under 510(k) number K921538.

Who is the listed applicant for AMALGAPHASE?

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

What is the FDA product code for AMALGAPHASE?

The FDA product code for AMALGAPHASE is EJJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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