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FDA 510(k)

BIONECT HYDROGEL

K-Number: K984413 · 1999-02-10

ApplicantFidia Pharmaceutical Corp.
Decision Date1999-02-10
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

BIONECT HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Fidia Pharmaceutical Corp.. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K984413. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONECT HYDROGEL?

BIONECT HYDROGEL is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Fidia Pharmaceutical Corp.. The 510(k) number is K984413.

When did BIONECT HYDROGEL receive FDA 510(k) clearance?

BIONECT HYDROGEL received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984413.

Who is the listed applicant for BIONECT HYDROGEL?

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

What is the FDA product code for BIONECT HYDROGEL?

The FDA product code for BIONECT HYDROGEL is MGQ.

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Other records listing Fidia Pharmaceutical Corp. 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.

K984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADSK984264MODIFICATION OF BIONECT CLEAR HYDROGELK984267MODIFICATION OF BIONECT HYDROGEL FOAMK984266MODIFICATION OF BIONECT HYDROGEL SPRAYK973722BIONECT HYDROGEL FOAMK973725BIONECT CLEAR HYDROGEL

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Related Devices (Code: MGQ)

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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