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FDA 510(k)

ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE

K-Number: K994137 · 2000-09-13

ApplicantAtrix Laboratories, Inc.
Decision Date2000-09-13
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE is the device name listed in this FDA 510(k) record. The listed applicant is Atrix Laboratories, Inc.. It received FDA 510(k) clearance on 2000-09-13 under 510(k) number K994137. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE?

ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE is a medical device that received FDA 510(k) clearance on 2000-09-13. The listed applicant is Atrix Laboratories, Inc.. The 510(k) number is K994137.

When did ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE receive FDA 510(k) clearance?

ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE received FDA 510(k) clearance on 2000-09-13, under 510(k) number K994137.

Who is the listed applicant for ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE?

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

What is the FDA product code for ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE?

The FDA product code for ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE is LYC.

Related Clinical Trials

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Other records listing Atrix Laboratories, 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.

K982865ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KITK955838ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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