FDA 510(k)

ソレヴィー・コーポレーション・LLC シリコンベースのパーソナル・ルブリカント

K番号: K203644 · 2021-04-19

決定日2021-04-19

製品コードNUC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Solevy Co. LLC Silicone Based Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Solevy Co., LLC. It received FDA 510(k) clearance on 2021-04-19 under 510(k) number K203644. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Solevy Co. LLC Silicone Based Personal Lubricant?

Solevy Co. LLC Silicone Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Solevy Co., LLC. The 510(k) number is K203644.

When did Solevy Co. LLC Silicone Based Personal Lubricant receive FDA 510(k) clearance?

Solevy Co. LLC Silicone Based Personal Lubricant received FDA 510(k) clearance on 2021-04-19, under 510(k) number K203644.

Who is the listed applicant for Solevy Co. LLC Silicone Based Personal Lubricant?

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

What is the FDA product code for Solevy Co. LLC Silicone Based Personal Lubricant?

The FDA product code for Solevy Co. LLC Silicone Based Personal Lubricant is NUC.

申請者としてSolevy Co., LLCを記載するその他の記録

K203654ソレヴィー・コー・LLC ウォーターベースのパーソナル・ルブリカント

公式ソース

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