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FDA 510(k)

BIOLEX WOUND GEL,

K-Number: K920050 · 1992-04-07

ApplicantCatalina Biomedical Corp.
Decision Date1992-04-07
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIOLEX WOUND GEL, is the device name listed in this FDA 510(k) record. The listed applicant is Catalina Biomedical Corp.. It received FDA 510(k) clearance on 1992-04-07 under 510(k) number K920050. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BIOLEX WOUND GEL,?

BIOLEX WOUND GEL, is a medical device that received FDA 510(k) clearance on 1992-04-07. The listed applicant is Catalina Biomedical Corp.. The 510(k) number is K920050.

When did BIOLEX WOUND GEL, receive FDA 510(k) clearance?

BIOLEX WOUND GEL, received FDA 510(k) clearance on 1992-04-07, under 510(k) number K920050.

Who is the listed applicant for BIOLEX WOUND GEL,?

The FDA 510(k) record lists Catalina Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLEX WOUND GEL,?

The FDA product code for BIOLEX WOUND GEL, is MGQ.

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Other records listing Catalina Biomedical 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.

K913480WOUND CARE TRAY AK913479WOUND CARE TRAY BK896358VARI/MOIST WOUND DRESSINGK896421TRANSPARENT FILM I.V. SITE/WOUND DRESSING

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.

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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.

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