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FDA 510(k)

AMALGAMATOR MODEL SDC--

K-Number: K791410 · 1979-09-19

ApplicantSierra Laboratories, Inc.
Decision Date1979-09-19
Product CodeEFD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AMALGAMATOR MODEL SDC-- is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1979-09-19 under 510(k) number K791410. The device is classified under product code EFD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMALGAMATOR MODEL SDC--?

AMALGAMATOR MODEL SDC-- is a medical device that received FDA 510(k) clearance on 1979-09-19. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K791410.

When did AMALGAMATOR MODEL SDC-- receive FDA 510(k) clearance?

AMALGAMATOR MODEL SDC-- received FDA 510(k) clearance on 1979-09-19, under 510(k) number K791410.

Who is the listed applicant for AMALGAMATOR MODEL SDC--?

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

What is the FDA product code for AMALGAMATOR MODEL SDC--?

The FDA product code for AMALGAMATOR MODEL SDC-- is EFD.

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Related Devices (Code: EFD)

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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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