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FDA 510(k)

BIAFINE WOUND DRESSING EMULSION

K-Number: K964240 · 1997-01-22

ApplicantMedix Pharmaceuticals Americas, Inc.
Decision Date1997-01-22
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

BIAFINE WOUND DRESSING EMULSION is the device name listed in this FDA 510(k) record. The listed applicant is Medix Pharmaceuticals Americas, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K964240. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIAFINE WOUND DRESSING EMULSION?

BIAFINE WOUND DRESSING EMULSION is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Medix Pharmaceuticals Americas, Inc.. The 510(k) number is K964240.

When did BIAFINE WOUND DRESSING EMULSION receive FDA 510(k) clearance?

BIAFINE WOUND DRESSING EMULSION received FDA 510(k) clearance on 1997-01-22, under 510(k) number K964240.

Who is the listed applicant for BIAFINE WOUND DRESSING EMULSION?

The FDA 510(k) record lists Medix Pharmaceuticals Americas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIAFINE WOUND DRESSING EMULSION?

The FDA product code for BIAFINE WOUND DRESSING EMULSION is MGQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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