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FDA 510(k)

XSE

K-Number: K011167 · 2001-05-17

Applicant3M Company
Decision Date2001-05-17
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XSE is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2001-05-17 under 510(k) number K011167. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XSE?

XSE is a medical device that received FDA 510(k) clearance on 2001-05-17. The listed applicant is 3M Company. The 510(k) number is K011167.

When did XSE receive FDA 510(k) clearance?

XSE received FDA 510(k) clearance on 2001-05-17, under 510(k) number K011167.

Who is the listed applicant for XSE?

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 XSE?

The FDA product code for XSE is KLE.

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.

View all 322 devices →

Related Devices (Code: KLE)

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.

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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