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FDA 510(k)

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD

K-Number: K100261 · 2010-12-10

ApplicantTei Biosciences, Inc.
Decision Date2010-12-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Tei Biosciences, Inc.. It received FDA 510(k) clearance on 2010-12-10 under 510(k) number K100261. 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 PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD?

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD is a medical device that received FDA 510(k) clearance on 2010-12-10. The listed applicant is Tei Biosciences, Inc.. The 510(k) number is K100261.

When did PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD receive FDA 510(k) clearance?

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD received FDA 510(k) clearance on 2010-12-10, under 510(k) number K100261.

Who is the listed applicant for PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD?

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

What is the FDA product code for PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD?

The FDA product code for PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD is FRO. This falls under the Anesthesiology category.

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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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