Biolex Wound Gel,

FDA 510(k) K920050 · Catalina Biomedical Corp.

Substantially Equivalent for Some Indications

510(k) numberK920050

Submission

Device name
Biolex Wound Gel,
Applicant
Catalina Biomedical Corp.
Duarte, CA, US
Received
January 6, 1992
Decision date
April 7, 1992
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device class
Unclassified

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Questions and answers

When was Biolex Wound Gel, cleared by the FDA?

Biolex Wound Gel, (K920050) received a 510(k) decision of Substantially Equivalent for Some Indications on April 7, 1992, 92 days after the submission was received.

What is the product code of K920050?

The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.