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FDA 510(k)

BIO 1-KIT BIOSORB FILLED CARTRIDGE

K-Number: K061022 · 2006-05-24

ApplicantScience For Biomaterials
Decision Date2006-05-24
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIO 1-KIT BIOSORB FILLED CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Science For Biomaterials. It received FDA 510(k) clearance on 2006-05-24 under 510(k) number K061022. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO 1-KIT BIOSORB FILLED CARTRIDGE?

BIO 1-KIT BIOSORB FILLED CARTRIDGE is a medical device that received FDA 510(k) clearance on 2006-05-24. The listed applicant is Science For Biomaterials. The 510(k) number is K061022.

When did BIO 1-KIT BIOSORB FILLED CARTRIDGE receive FDA 510(k) clearance?

BIO 1-KIT BIOSORB FILLED CARTRIDGE received FDA 510(k) clearance on 2006-05-24, under 510(k) number K061022.

Who is the listed applicant for BIO 1-KIT BIOSORB FILLED CARTRIDGE?

The FDA 510(k) record lists Science For Biomaterials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO 1-KIT BIOSORB FILLED CARTRIDGE?

The FDA product code for BIO 1-KIT BIOSORB FILLED CARTRIDGE is MQV.

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Other records listing Science For Biomaterials 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: MQV)

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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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