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FDA 510(k)

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

K-Number: K991287 · 1999-06-29

ApplicantAdvanced Medical Solutions Group Plc
Decision Date1999-06-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Solutions Group Plc. It received FDA 510(k) clearance on 1999-06-29 under 510(k) number K991287. 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 SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA?

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Advanced Medical Solutions Group Plc. The 510(k) number is K991287.

When did SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA receive FDA 510(k) clearance?

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991287.

Who is the listed applicant for SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA?

The FDA 510(k) record lists Advanced Medical Solutions Group Plc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA?

The FDA product code for SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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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Other records listing Advanced Medical Solutions Group Plc 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.

K991630ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

View on FDA Database →

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

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