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FDA 510(k)

DRY GEL

K-Number: K833441 · 1983-11-29

ApplicantConcept, Inc.
Decision Date1983-11-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRY GEL is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1983-11-29 under 510(k) number K833441. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRY GEL?

DRY GEL is a medical device that received FDA 510(k) clearance on 1983-11-29. The listed applicant is Concept, Inc.. The 510(k) number is K833441.

When did DRY GEL receive FDA 510(k) clearance?

DRY GEL received FDA 510(k) clearance on 1983-11-29, under 510(k) number K833441.

Who is the listed applicant for DRY GEL?

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

What is the FDA product code for DRY GEL?

The FDA product code for DRY GEL is GEI.

Other records listing Concept, Inc. as applicant

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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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