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FDA 510(k)

ELECTROLYTE GEL

K-Number: K813370 · 1981-12-22

ApplicantHi Chem, Inc.
Decision Date1981-12-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELECTROLYTE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1981-12-22 under 510(k) number K813370. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROLYTE GEL?

ELECTROLYTE GEL is a medical device that received FDA 510(k) clearance on 1981-12-22. The listed applicant is Hi Chem, Inc.. The 510(k) number is K813370.

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

ELECTROLYTE GEL received FDA 510(k) clearance on 1981-12-22, under 510(k) number K813370.

Who is the listed applicant for ELECTROLYTE GEL?

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

What is the FDA product code for ELECTROLYTE GEL?

The FDA product code for ELECTROLYTE GEL is CGA.

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Related Devices (Code: CGA)

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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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