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FDA 510(k)

TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8

K-Number: K061060 · 2006-07-03

ApplicantTissue Technologies Holdings, LLC
Decision Date2006-07-03
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Technologies Holdings, LLC. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061060. 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 TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8?

TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Tissue Technologies Holdings, LLC. The 510(k) number is K061060.

When did TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 receive FDA 510(k) clearance?

TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061060.

Who is the listed applicant for TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8?

The FDA 510(k) record lists Tissue Technologies Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8?

The FDA product code for TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8 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 Tissue Technologies Holdings, LLC 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.

K081246TT-102

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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