FDA 510(k)

파쿼에밀리파이션 나일론(추) 및 이식 부츠

K-번호: K192418 · 2020-05-27

결정일2020-05-27

제품 코드HQC

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

Phacoemulsification Needle (Tip) and Irrigation Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Raico, LLC. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K192418. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Phacoemulsification Needle (Tip) and Irrigation Sleeve?

Phacoemulsification Needle (Tip) and Irrigation Sleeve is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Raico, LLC. The 510(k) number is K192418.

When did Phacoemulsification Needle (Tip) and Irrigation Sleeve receive FDA 510(k) clearance?

Phacoemulsification Needle (Tip) and Irrigation Sleeve received FDA 510(k) clearance on 2020-05-27, under 510(k) number K192418.

Who is the listed applicant for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

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

What is the FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve?

The FDA product code for Phacoemulsification Needle (Tip) and Irrigation Sleeve is HQC.

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파쿼에밀리파이션 나일론(추) 및 이식 부츠

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: HQC)

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