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FDA 510(k)

ESSENTIAL SHAVER SYSTEM

K-Number: K974232 · 1998-01-12

ApplicantGyrus Ent LLC
Decision Date1998-01-12
Product CodeEQJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ESSENTIAL SHAVER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Ent LLC. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K974232. The device is classified under product code EQJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSENTIAL SHAVER SYSTEM?

ESSENTIAL SHAVER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Gyrus Ent LLC. The 510(k) number is K974232.

When did ESSENTIAL SHAVER SYSTEM receive FDA 510(k) clearance?

ESSENTIAL SHAVER SYSTEM received FDA 510(k) clearance on 1998-01-12, under 510(k) number K974232.

Who is the listed applicant for ESSENTIAL SHAVER SYSTEM?

The FDA 510(k) record lists Gyrus Ent LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESSENTIAL SHAVER SYSTEM?

The FDA product code for ESSENTIAL SHAVER SYSTEM is EQJ.

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Other records listing Gyrus Ent LLC as applicant

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Related Devices (Code: EQJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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