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FDA 510(k)

COLLAGEN-ORC ANTIMICROBIAL MATRIX

K-Number: K033523 · 2004-10-21

ApplicantJohnson & Johnson Medical, Ltd.
Decision Date2004-10-21
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

COLLAGEN-ORC ANTIMICROBIAL MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Ltd.. It received FDA 510(k) clearance on 2004-10-21 under 510(k) number K033523. 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 COLLAGEN-ORC ANTIMICROBIAL MATRIX?

COLLAGEN-ORC ANTIMICROBIAL MATRIX is a medical device that received FDA 510(k) clearance on 2004-10-21. The listed applicant is Johnson & Johnson Medical, Ltd.. The 510(k) number is K033523.

When did COLLAGEN-ORC ANTIMICROBIAL MATRIX receive FDA 510(k) clearance?

COLLAGEN-ORC ANTIMICROBIAL MATRIX received FDA 510(k) clearance on 2004-10-21, under 510(k) number K033523.

Who is the listed applicant for COLLAGEN-ORC ANTIMICROBIAL MATRIX?

The FDA 510(k) record lists Johnson & Johnson Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLAGEN-ORC ANTIMICROBIAL MATRIX?

The FDA product code for COLLAGEN-ORC ANTIMICROBIAL MATRIX is FRO. This falls under the Anesthesiology category.

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Other records listing Johnson & Johnson Medical, 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.

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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

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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