FDA 510(k)

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K-번호: K181194 · 2019-02-15

결정일2019-02-15

제품 코드LFD

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SmartMouth DryMouth Oral Rinse is the device name listed in this FDA 510(k) record. The listed applicant is Triumph Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K181194. The device is classified under product code LFD. FDA Decision: Substantially Equivalent.

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What is the SmartMouth DryMouth Oral Rinse?

SmartMouth DryMouth Oral Rinse is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Triumph Pharmaceuticals, Inc.. The 510(k) number is K181194.

When did SmartMouth DryMouth Oral Rinse receive FDA 510(k) clearance?

SmartMouth DryMouth Oral Rinse received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181194.

Who is the listed applicant for SmartMouth DryMouth Oral Rinse?

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

What is the FDA product code for SmartMouth DryMouth Oral Rinse?

The FDA product code for SmartMouth DryMouth Oral Rinse is LFD.

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관련 임상시험

관련 기기 (코드: LFD)

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