FDA 510(k)

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

Número K: K211571 · 2022-05-31

RequerenteZhejiang Longterm Medical Technology Co., Ltd.

Data da decisão2022-05-31

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-31 under 510(k) number K211571. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is a medical device that received FDA 510(k) clearance on 2022-05-31. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K211571.

When did Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit receive FDA 510(k) clearance?

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit received FDA 510(k) clearance on 2022-05-31, under 510(k) number K211571.

Who is the listed applicant for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit?

The FDA product code for Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit is OMP.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Zhejiang Longterm Medical Technology Co., Ltd. como candidato(a)

K254246LT Antibacterial Foam with Silver Dressing K202823Innomed NPWT Silicone Foam Dressing K192478LT Antibacterial Alginate with Silver Dressing K182458Longterm NPWT Foam Dressing Kit

Dispositivos Relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.