FDA 510(k)

SB 칼/단형, SB 칼/표준형, SB 칼/Jr형, SB 칼/Jr형 - 장형

K-번호: K190621 · 2019-04-23

결정일2019-04-23

제품 코드KNS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Bakelite Co., Ltd.. It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K190621. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K190621.

When did SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long receive FDA 510(k) clearance?

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long received FDA 510(k) clearance on 2019-04-23, under 510(k) number K190621.

Who is the listed applicant for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

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

What is the FDA product code for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long?

The FDA product code for SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long is KNS.

Sumitomo Bakelite Co., Ltd.를 신청인으로 등재한 기타 기록

K182520유연한 오버튜브 K173004SB 소프트 히트 - 직립형, SB 소프트 히트 - 아래쪽 절단형 K152771SB 나이프 Jr 타입, SB 나이프 쇼트 타입, SB 나이프 스탠더드 타입, SB 나이프 Jr 타입 - 롱

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