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 a medical device manufactured by Hrs Co., Ltd.. It received FDA 510(k) clearance on 2018-11-28 under approval 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. It is manufactured by Hrs Co., Ltd.. The 510(k) number is K181604.
When was Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite approved by the FDA?
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite received FDA 510(k) clearance on 2018-11-28, under approval number K181604.
What company makes Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite?
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite is manufactured by Hrs Co., Ltd..
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)
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.