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FDA 510(k)

SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC

K-Number: K050649 · 2005-06-13

ApplicantNoble Fiber Technologies, Inc.
Decision Date2005-06-13
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC is the device name listed in this FDA 510(k) record. The listed applicant is Noble Fiber Technologies, Inc.. It received FDA 510(k) clearance on 2005-06-13 under 510(k) number K050649. 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 SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC?

SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC is a medical device that received FDA 510(k) clearance on 2005-06-13. The listed applicant is Noble Fiber Technologies, Inc.. The 510(k) number is K050649.

When did SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC receive FDA 510(k) clearance?

SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC received FDA 510(k) clearance on 2005-06-13, under 510(k) number K050649.

Who is the listed applicant for SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC?

The FDA 510(k) record lists Noble Fiber Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC?

The FDA product code for SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC is FRO. This falls under the Anesthesiology category.

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Other records listing Noble Fiber Technologies, Inc. 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.

K063190SILVERSEAL WOUND PACKING STRIPS WITH X-STATICK050726SILVERSEAL SILVERAID WITH X-STATICK051256SILVERSEAL ORTHOTIC COMPONENT WITH X-STATICK043526SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

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

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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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