FDA 510(k)

BIONECT CREAM

K-Number: K963004 · 1997-02-12

Decision Date1997-02-12

Product CodeMGQ

DecisionSubstantially Equivalent for Some Indications

Device Summary

BIONECT CREAM 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 1997-02-12 under 510(k) number K963004. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIONECT CREAM?

BIONECT CREAM is a medical device that received FDA 510(k) clearance on 1997-02-12. The listed applicant is Fidia Pharmaceutical Corp.. The 510(k) number is K963004.

When did BIONECT CREAM receive FDA 510(k) clearance?

BIONECT CREAM received FDA 510(k) clearance on 1997-02-12, under 510(k) number K963004.

Who is the listed applicant for BIONECT CREAM?

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 CREAM?

The FDA product code for BIONECT CREAM 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 K984266MODIFICATION OF BIONECT HYDROGEL SPRAY K984262MODIFICATION OF BIONECT HYDROGEL GAUZE PADS K973721BIONECT HYDROGEL GAUZE PADS

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Related Devices (Code: MGQ)

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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.