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FDA 510(k)

SILVERSTREAM AND DERMASEPT

K-Number: K093227 · 2009-12-10

ApplicantEnzysurge , Ltd.
Decision Date2009-12-10
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

SILVERSTREAM AND DERMASEPT is the device name listed in this FDA 510(k) record. The listed applicant is Enzysurge , Ltd.. It received FDA 510(k) clearance on 2009-12-10 under 510(k) number K093227. 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 SILVERSTREAM AND DERMASEPT?

SILVERSTREAM AND DERMASEPT is a medical device that received FDA 510(k) clearance on 2009-12-10. The listed applicant is Enzysurge , Ltd.. The 510(k) number is K093227.

When did SILVERSTREAM AND DERMASEPT receive FDA 510(k) clearance?

SILVERSTREAM AND DERMASEPT received FDA 510(k) clearance on 2009-12-10, under 510(k) number K093227.

Who is the listed applicant for SILVERSTREAM AND DERMASEPT?

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

What is the FDA product code for SILVERSTREAM AND DERMASEPT?

The FDA product code for SILVERSTREAM AND DERMASEPT is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Enzysurge , Ltd. 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.

K200767SilverStream GelK060046DERMASTREAM

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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