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FDA 510(k)

DERMOLAS

K-Number: K832983 · 1984-04-23

ApplicantMeditec, Inc.
Decision Date1984-04-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMOLAS is the device name listed in this FDA 510(k) record. The listed applicant is Meditec, Inc.. It received FDA 510(k) clearance on 1984-04-23 under 510(k) number K832983. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMOLAS?

DERMOLAS is a medical device that received FDA 510(k) clearance on 1984-04-23. The listed applicant is Meditec, Inc.. The 510(k) number is K832983.

When did DERMOLAS receive FDA 510(k) clearance?

DERMOLAS received FDA 510(k) clearance on 1984-04-23, under 510(k) number K832983.

Who is the listed applicant for DERMOLAS?

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

What is the FDA product code for DERMOLAS?

The FDA product code for DERMOLAS is GEX. This falls under the Gastroenterology category.

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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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