FDA 510(k)

SancDam Latex Oral Dam

K-번호: K212037 · 2022-03-28

결정일2022-03-28

제품 코드MSC

자문 위원회OB

결정Substantially Equivalent

기기 요약

SancDam Latex Oral Dam is the device name listed in this FDA 510(k) record. The listed applicant is Sanctuary Health Sdn. Bhd.. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K212037. The device is classified under product code MSC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SancDam Latex Oral Dam?

SancDam Latex Oral Dam is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Sanctuary Health Sdn. Bhd.. The 510(k) number is K212037.

When did SancDam Latex Oral Dam receive FDA 510(k) clearance?

SancDam Latex Oral Dam received FDA 510(k) clearance on 2022-03-28, under 510(k) number K212037.

Who is the listed applicant for SancDam Latex Oral Dam?

The FDA 510(k) record lists Sanctuary Health Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SancDam Latex Oral Dam?

The FDA product code for SancDam Latex Oral Dam is MSC.

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SancDam Latex Oral Dam

기기 요약

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관련 임상시험

관련 기기 (코드: MSC)

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