FDA 510(k)

ReNew Sterilization Trays(Catalog #3708 and #3709)

Número K: K152745 · 2016-05-12

Data da decisão2016-05-12

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ReNew Sterilization Trays(Catalog #3708 and #3709) is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K152745. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ReNew Sterilization Trays(Catalog #3708 and #3709)?

ReNew Sterilization Trays(Catalog #3708 and #3709) is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152745.

When did ReNew Sterilization Trays(Catalog #3708 and #3709) receive FDA 510(k) clearance?

ReNew Sterilization Trays(Catalog #3708 and #3709) received FDA 510(k) clearance on 2016-05-12, under 510(k) number K152745.

Who is the listed applicant for ReNew Sterilization Trays(Catalog #3708 and #3709)?

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

What is the FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709)?

The FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709) is KCT.

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Outros registros que listam Microline Surgical, Inc. como candidato(a)

K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)K213127ReNew Disposable Scissor Tips K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm K160706ReNew V Handpiece Laparoscopic Instruments K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

Dispositivos Relacionados (Código: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.

Fonte oficial

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