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FDA 510(k)

BIATAIN FOAM ADHESIVE DRESSING

K-Number: K983173 · 1998-12-16

ApplicantColoplast Corp.
Decision Date1998-12-16
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

BIATAIN FOAM ADHESIVE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983173. 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 BIATAIN FOAM ADHESIVE DRESSING?

BIATAIN FOAM ADHESIVE DRESSING is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Coloplast Corp.. The 510(k) number is K983173.

When did BIATAIN FOAM ADHESIVE DRESSING receive FDA 510(k) clearance?

BIATAIN FOAM ADHESIVE DRESSING received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983173.

Who is the listed applicant for BIATAIN FOAM ADHESIVE DRESSING?

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

What is the FDA product code for BIATAIN FOAM ADHESIVE DRESSING?

The FDA product code for BIATAIN FOAM ADHESIVE DRESSING is FRO. This falls under the Anesthesiology category.

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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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