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FDA 510(k)

DI CUSTOM IN THE EAR AND IN THE CANAL

K-Number: K920657 · 1992-03-31

ApplicantDakota Laboratories, Inc.
Decision Date1992-03-31
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DI CUSTOM IN THE EAR AND IN THE CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Dakota Laboratories, Inc.. It received FDA 510(k) clearance on 1992-03-31 under 510(k) number K920657. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DI CUSTOM IN THE EAR AND IN THE CANAL?

DI CUSTOM IN THE EAR AND IN THE CANAL is a medical device that received FDA 510(k) clearance on 1992-03-31. The listed applicant is Dakota Laboratories, Inc.. The 510(k) number is K920657.

When did DI CUSTOM IN THE EAR AND IN THE CANAL receive FDA 510(k) clearance?

DI CUSTOM IN THE EAR AND IN THE CANAL received FDA 510(k) clearance on 1992-03-31, under 510(k) number K920657.

Who is the listed applicant for DI CUSTOM IN THE EAR AND IN THE CANAL?

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

What is the FDA product code for DI CUSTOM IN THE EAR AND IN THE CANAL?

The FDA product code for DI CUSTOM IN THE EAR AND IN THE CANAL is ESD.

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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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