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FDA 510(k)

OMIDERM WOUND & BURN DRESSING

K-Number: K851885 · 1985-11-25

ApplicantBiosystems Assoc.
Decision Date1985-11-25
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

OMIDERM WOUND & BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Biosystems Assoc.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K851885. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OMIDERM WOUND & BURN DRESSING?

OMIDERM WOUND & BURN DRESSING is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Biosystems Assoc.. The 510(k) number is K851885.

When did OMIDERM WOUND & BURN DRESSING receive FDA 510(k) clearance?

OMIDERM WOUND & BURN DRESSING received FDA 510(k) clearance on 1985-11-25, under 510(k) number K851885.

Who is the listed applicant for OMIDERM WOUND & BURN DRESSING?

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

What is the FDA product code for OMIDERM WOUND & BURN DRESSING?

The FDA product code for OMIDERM WOUND & BURN DRESSING is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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