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FDA 510(k)

HYALOMATRIX CO

K-Number: K003855 · 2001-07-03

ApplicantFidia Advanced Biopolymers Srl
Decision Date2001-07-03
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HYALOMATRIX CO is the device name listed in this FDA 510(k) record. The listed applicant is Fidia Advanced Biopolymers Srl. It received FDA 510(k) clearance on 2001-07-03 under 510(k) number K003855. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYALOMATRIX CO?

HYALOMATRIX CO is a medical device that received FDA 510(k) clearance on 2001-07-03. The listed applicant is Fidia Advanced Biopolymers Srl. The 510(k) number is K003855.

When did HYALOMATRIX CO receive FDA 510(k) clearance?

HYALOMATRIX CO received FDA 510(k) clearance on 2001-07-03, under 510(k) number K003855.

Who is the listed applicant for HYALOMATRIX CO?

The FDA 510(k) record lists Fidia Advanced Biopolymers Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYALOMATRIX CO?

The FDA product code for HYALOMATRIX CO is KHJ.

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 Fidia Advanced Biopolymers Srl 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.

K092257JALOSKINK073251HYALOMATRIX PAK001508LASERSKIN DRESSING

Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , 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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