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FDA 510(k)

AMALGAM ALLOY

K-Number: K780997 · 1978-07-27

ApplicantSyntex Corp.
Decision Date1978-07-27
Product CodeEJJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAM ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Corp.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780997. 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 AMALGAM ALLOY?

AMALGAM ALLOY is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Syntex Corp.. The 510(k) number is K780997.

When did AMALGAM ALLOY receive FDA 510(k) clearance?

AMALGAM ALLOY received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780997.

Who is the listed applicant for AMALGAM ALLOY?

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

What is the FDA product code for AMALGAM ALLOY?

The FDA product code for AMALGAM ALLOY is EJJ.

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Other records listing Syntex Corp. as applicant

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K920314TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K843593SURGIPRESS SURGICAL LOOPK780769S-100 CT SCANNERK780483FIBER OPTIC HANDPIECEK761331OPUS I OPTION - FIBER OPTIC L SYSTEMK761332HI-SENSITIVITY MODE OPTION FOR S60-1A

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Related Devices (Code: 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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