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FDA 510(k)

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

K-Number: K181604 · 2018-11-28

ApplicantHrs Co., Ltd.
Decision Date2018-11-28
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is the device name listed in this FDA 510(k) record. The listed applicant is Hrs Co., Ltd.. It received FDA 510(k) clearance on 2018-11-28 under 510(k) number K181604. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is Hrs Co., Ltd.. The 510(k) number is K181604.

When did Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite receive FDA 510(k) clearance?

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite received FDA 510(k) clearance on 2018-11-28, under 510(k) number K181604.

Who is the listed applicant for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

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

What is the FDA product code for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?

The FDA product code for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is ELW.

Related Devices (Code: ELW)

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

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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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