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FDA 510(k)

MODIFICATION OF BIONECT HYDROGEL GAUZE PADS

K-Number: K984262 · 1999-02-10

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

Device Summary

MODIFICATION OF BIONECT HYDROGEL GAUZE PADS 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 K984262. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF BIONECT HYDROGEL GAUZE PADS?

MODIFICATION OF BIONECT HYDROGEL GAUZE PADS 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 K984262.

When did MODIFICATION OF BIONECT HYDROGEL GAUZE PADS receive FDA 510(k) clearance?

MODIFICATION OF BIONECT HYDROGEL GAUZE PADS received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984262.

Who is the listed applicant for MODIFICATION OF BIONECT HYDROGEL GAUZE PADS?

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 MODIFICATION OF BIONECT HYDROGEL GAUZE PADS?

The FDA product code for MODIFICATION OF BIONECT HYDROGEL GAUZE PADS 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.

K984413BIONECT HYDROGELK984264MODIFICATION 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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