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FDA 510(k)

BIONECT CLEAR HYDROGEL

K-Number: K973725 · 1998-09-22

ApplicantFidia Pharmaceutical Corp.
Decision Date1998-09-22
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

BIONECT CLEAR 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 1998-09-22 under 510(k) number K973725. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONECT CLEAR HYDROGEL?

BIONECT CLEAR HYDROGEL is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Fidia Pharmaceutical Corp.. The 510(k) number is K973725.

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

BIONECT CLEAR HYDROGEL received FDA 510(k) clearance on 1998-09-22, under 510(k) number K973725.

Who is the listed applicant for BIONECT CLEAR 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 CLEAR HYDROGEL?

The FDA product code for BIONECT CLEAR 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.

K984413BIONECT HYDROGELK984264MODIFICATION OF BIONECT CLEAR HYDROGELK984267MODIFICATION OF BIONECT HYDROGEL FOAMK984266MODIFICATION OF BIONECT HYDROGEL SPRAYK984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADSK973721BIONECT HYDROGEL GAUZE PADS

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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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