FDA 510(k)

HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES

Numéro K : K183009 · 2018-11-26

DemandeurHemostatix Medical Technologies, LLC

Date de décision2018-11-26

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Hemostatix Medical Technologies, LLC. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K183009. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES?

HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Hemostatix Medical Technologies, LLC. The 510(k) number is K183009.

When did HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES receive FDA 510(k) clearance?

HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES received FDA 510(k) clearance on 2018-11-26, under 510(k) number K183009.

Who is the listed applicant for HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES?

The FDA 510(k) record lists Hemostatix Medical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES?

The FDA product code for HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES is GEI.

Essais cliniques associés

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Source officielle

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