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FDA 510(k)

Suprasorb A + Ag “R”

K-Number: K183208 · 2019-08-15

ApplicantSpeciality Fibres and Materials, Ltd.
Decision Date2019-08-15
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Suprasorb A + Ag “R” is the device name listed in this FDA 510(k) record. The listed applicant is Speciality Fibres and Materials, Ltd.. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K183208. 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 Suprasorb A + Ag “R”?

Suprasorb A + Ag “R” is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Speciality Fibres and Materials, Ltd.. The 510(k) number is K183208.

When did Suprasorb A + Ag “R” receive FDA 510(k) clearance?

Suprasorb A + Ag “R” received FDA 510(k) clearance on 2019-08-15, under 510(k) number K183208.

Who is the listed applicant for Suprasorb A + Ag “R”?

The FDA 510(k) record lists Speciality Fibres and Materials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Suprasorb A + Ag “R”?

The FDA product code for Suprasorb A + Ag “R” is FRO. This falls under the Anesthesiology category.

Other records listing Speciality Fibres and Materials, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmK222740Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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