FDA 510(k)

MODIFICATION OF BIONECT CLEAR HYDROGEL

K-Number: K984264 · 1999-02-10

Decision Date1999-02-10

Product CodeMGQ

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF 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 1999-02-10 under 510(k) number K984264. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF BIONECT CLEAR HYDROGEL?

MODIFICATION OF BIONECT CLEAR 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 K984264.

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

MODIFICATION OF BIONECT CLEAR HYDROGEL received FDA 510(k) clearance on 1999-02-10, under 510(k) number K984264.

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

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

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Other records listing Fidia Pharmaceutical Corp. as applicant

K984413BIONECT HYDROGEL K984267MODIFICATION OF BIONECT HYDROGEL FOAM K984266MODIFICATION OF BIONECT HYDROGEL SPRAY 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.