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FDA 510(k)

3M TEGADERM SILVER (AG) MESH

K-Number: K053256 · 2005-12-16

Applicant3M Company
Decision Date2005-12-16
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

3M TEGADERM SILVER (AG) MESH is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K053256. 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 3M TEGADERM SILVER (AG) MESH?

3M TEGADERM SILVER (AG) MESH is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is 3M Company. The 510(k) number is K053256.

When did 3M TEGADERM SILVER (AG) MESH receive FDA 510(k) clearance?

3M TEGADERM SILVER (AG) MESH received FDA 510(k) clearance on 2005-12-16, under 510(k) number K053256.

Who is the listed applicant for 3M TEGADERM SILVER (AG) MESH?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M TEGADERM SILVER (AG) MESH?

The FDA product code for 3M TEGADERM SILVER (AG) MESH is FRO. This falls under the Anesthesiology category.

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Other records listing 3M Company 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.

K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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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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