FDA 510(k)

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

K-번호: K171575 · 2017-10-24

결정일2017-10-24

제품 코드HQD

자문 위원회OP

결정Substantially Equivalent

기기 요약

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K171575. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is Contamac, Ltd.. The 510(k) number is K171575.

When did ENFLU 18 (enflufocon A) Daily Wear Contact Lens receive FDA 510(k) clearance?

ENFLU 18 (enflufocon A) Daily Wear Contact Lens received FDA 510(k) clearance on 2017-10-24, under 510(k) number K171575.

Who is the listed applicant for ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

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

What is the FDA product code for ENFLU 18 (enflufocon A) Daily Wear Contact Lens?

The FDA product code for ENFLU 18 (enflufocon A) Daily Wear Contact Lens is HQD.

Contamac, Ltd.를 신청인으로 등재한 기타 기록

K212631Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses K182304Hyper GP (tisilfocon A) Daily Wear Contact Lens K181566Nutrifill K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens K171077HEXA100 (hexafocon A) Daily Wear Contact Lenses K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses

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