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FDA 510(k)

TL TRISEB CREAM

K-Number: K121134 · 2012-07-25

ApplicantTrigen Laboratories, Inc.
Decision Date2012-07-25
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TL TRISEB CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Trigen Laboratories, Inc.. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K121134. 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 TL TRISEB CREAM?

TL TRISEB CREAM is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Trigen Laboratories, Inc.. The 510(k) number is K121134.

When did TL TRISEB CREAM receive FDA 510(k) clearance?

TL TRISEB CREAM received FDA 510(k) clearance on 2012-07-25, under 510(k) number K121134.

Who is the listed applicant for TL TRISEB CREAM?

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

What is the FDA product code for TL TRISEB CREAM?

The FDA product code for TL TRISEB CREAM is FRO. This falls under the Anesthesiology category.

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Other records listing Trigen Laboratories, Inc. 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.

K110762AVO BARRIER TOPICAL EMULSIONK110757TL-CERMIDE SKIN BARRIER EMULSION

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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