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FDA 510(k)

BIONECT HYDROGEL SPRAY

K-Number: K973724 · 1998-09-22

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

Device Summary

BIONECT HYDROGEL SPRAY 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 K973724. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONECT HYDROGEL SPRAY?

BIONECT HYDROGEL SPRAY 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 K973724.

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

BIONECT HYDROGEL SPRAY received FDA 510(k) clearance on 1998-09-22, under 510(k) number K973724.

Who is the listed applicant for BIONECT HYDROGEL SPRAY?

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 SPRAY?

The FDA product code for BIONECT HYDROGEL SPRAY 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 PADSK973725BIONECT 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.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, Inc.

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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