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FDA 510(k)

TITANALOY SUBMERSIBLE IMPLANT SYSTEM

K-Number: K830414 · 1983-03-24

ApplicantBoehringer/Miter, Inc.
Decision Date1983-03-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TITANALOY SUBMERSIBLE IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer/Miter, Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830414. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANALOY SUBMERSIBLE IMPLANT SYSTEM?

TITANALOY SUBMERSIBLE IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Boehringer/Miter, Inc.. The 510(k) number is K830414.

When did TITANALOY SUBMERSIBLE IMPLANT SYSTEM receive FDA 510(k) clearance?

TITANALOY SUBMERSIBLE IMPLANT SYSTEM received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830414.

Who is the listed applicant for TITANALOY SUBMERSIBLE IMPLANT SYSTEM?

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

What is the FDA product code for TITANALOY SUBMERSIBLE IMPLANT SYSTEM?

The FDA product code for TITANALOY SUBMERSIBLE IMPLANT SYSTEM is DZE.

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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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