FDA 510(k)

3M Tegaderm Pansement Transparent Antimicrobien, 3M Tegaderm Pansement Antimicrobien I.V. Avancé pour le Verrouillage Sécurisé

Numéro K : K170754 · 2017-11-21

Date de décision2017-11-21

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company, 3M Healthcare. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K170754. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing?

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is 3M Company, 3M Healthcare. The 510(k) number is K170754.

When did 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing receive FDA 510(k) clearance?

3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing received FDA 510(k) clearance on 2017-11-21, under 510(k) number K170754.

Who is the listed applicant for 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing?

The FDA 510(k) record lists 3M Company, 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing?

The FDA product code for 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing is FRO. This falls under the Anesthesiology category.

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Dispositifs connexes (Code : FRO)

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Source officielle

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