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FDA 510(k)

CURALINE POLYURETHANE FOAM AWC DRESSING

K-Number: K121361 · 2012-11-30

ApplicantCuraline, Inc.
Decision Date2012-11-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CURALINE POLYURETHANE FOAM AWC DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Curaline, Inc.. It received FDA 510(k) clearance on 2012-11-30 under 510(k) number K121361. 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.

Frequently Asked Questions

What is the CURALINE POLYURETHANE FOAM AWC DRESSING?

CURALINE POLYURETHANE FOAM AWC DRESSING is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Curaline, Inc.. The 510(k) number is K121361.

When did CURALINE POLYURETHANE FOAM AWC DRESSING receive FDA 510(k) clearance?

CURALINE POLYURETHANE FOAM AWC DRESSING received FDA 510(k) clearance on 2012-11-30, under 510(k) number K121361.

Who is the listed applicant for CURALINE POLYURETHANE FOAM AWC DRESSING?

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

What is the FDA product code for CURALINE POLYURETHANE FOAM AWC DRESSING?

The FDA product code for CURALINE POLYURETHANE FOAM AWC 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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