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FDA 510(k)

JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR

K-Number: K844093 · 1985-01-29

ApplicantJcm Labs, Inc.
Decision Date1985-01-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR is the device name listed in this FDA 510(k) record. The listed applicant is Jcm Labs, Inc.. It received FDA 510(k) clearance on 1985-01-29 under 510(k) number K844093. 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 JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR is a medical device that received FDA 510(k) clearance on 1985-01-29. The listed applicant is Jcm Labs, Inc.. The 510(k) number is K844093.

When did JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR receive FDA 510(k) clearance?

JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR received FDA 510(k) clearance on 1985-01-29, under 510(k) number K844093.

Who is the listed applicant for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

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

What is the FDA product code for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR?

The FDA product code for JCM LABS CUSTOM PRESCRIPTION & ACCENT IN-THE-EAR is ESD.

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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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