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FDA 510(k)

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing

K-Number: K210135 · 2022-02-24

Applicant3M Healthcare Business Group
Decision Date2022-02-24
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare Business Group. It received FDA 510(k) clearance on 2022-02-24 under 510(k) number K210135. 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.

Frequently Asked Questions

What is the PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing?

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is 3M Healthcare Business Group. The 510(k) number is K210135.

When did PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing receive FDA 510(k) clearance?

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing received FDA 510(k) clearance on 2022-02-24, under 510(k) number K210135.

Who is the listed applicant for PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing?

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

What is the FDA product code for PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing?

The FDA product code for PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing is FRO. This falls under the Anesthesiology category.

Other records listing 3M Healthcare Business Group as applicant

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Official Source

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