FDA 510(k)

SB 소프트 히트 - 직립형, SB 소프트 히트 - 아래쪽 절단형

K-번호: K173004 · 2018-05-08

결정일2018-05-08

제품 코드FDS

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

SB Soft Hood - Straight type, SB Soft Hood - Undercut type 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 2018-05-08 under 510(k) number K173004. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type is a medical device that received FDA 510(k) clearance on 2018-05-08. The listed applicant is Sumitomo Bakelite Co., Ltd.. The 510(k) number is K173004.

When did SB Soft Hood - Straight type, SB Soft Hood - Undercut type receive FDA 510(k) clearance?

SB Soft Hood - Straight type, SB Soft Hood - Undercut type received FDA 510(k) clearance on 2018-05-08, under 510(k) number K173004.

Who is the listed applicant for SB Soft Hood - Straight type, SB Soft Hood - Undercut type?

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 Soft Hood - Straight type, SB Soft Hood - Undercut type?

The FDA product code for SB Soft Hood - Straight type, SB Soft Hood - Undercut type is FDS.

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

K182520유연한 오버튜브 K190621SB 칼/단형, SB 칼/표준형, SB 칼/Jr형, SB 칼/Jr형 - 장형 K152771SB 나이프 Jr 타입, SB 나이프 쇼트 타입, SB 나이프 스탠더드 타입, SB 나이프 Jr 타입 - 롱

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