FDA 510(k)

MODIFICATION OF BIONECT HYDROGEL SPRAY

K-Number: K984266 · 1999-02-10

Decision Date1999-02-10

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF 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 1999-02-10 under 510(k) number K984266. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF BIONECT HYDROGEL SPRAY?

MODIFICATION OF BIONECT HYDROGEL SPRAY 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 K984266.

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

MODIFICATION OF BIONECT HYDROGEL SPRAY received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984266.

Who is the listed applicant for MODIFICATION OF 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 MODIFICATION OF BIONECT HYDROGEL SPRAY?

The FDA product code for MODIFICATION OF BIONECT HYDROGEL SPRAY is MGQ.

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Other records listing Fidia Pharmaceutical Corp. as applicant

K984413BIONECT HYDROGEL K984264MODIFICATION OF BIONECT CLEAR HYDROGEL K984267MODIFICATION OF BIONECT HYDROGEL FOAM K984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADS K973722BIONECT HYDROGEL FOAM K973725BIONECT CLEAR HYDROGEL

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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.