FDA 510(k)

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

K-번호: K170560 · 2017-04-04

결정일2017-04-04

제품 코드MQL

자문 위원회OB

결정Substantially Equivalent

기기 요약

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K170560. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K170560.

When did SAGE Vitrification Kit and SAGE Vitrification Warming Kit receive FDA 510(k) clearance?

SAGE Vitrification Kit and SAGE Vitrification Warming Kit received FDA 510(k) clearance on 2017-04-04, under 510(k) number K170560.

Who is the listed applicant for SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

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

What is the FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit?

The FDA product code for SAGE Vitrification Kit and SAGE Vitrification Warming Kit is MQL.

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