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FDA 510(k)

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation

K-Number: K210605 · 2021-04-29

Applicant3M Company
Decision Date2021-04-29
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2021-04-29 under 510(k) number K210605. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is a medical device that received FDA 510(k) clearance on 2021-04-29. The listed applicant is 3M Company. The 510(k) number is K210605.

When did 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation receive FDA 510(k) clearance?

3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation received FDA 510(k) clearance on 2021-04-29, under 510(k) number K210605.

Who is the listed applicant for 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

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 Bair Hugger Universal Warming Gown made with Thinsulate Insulation?

The FDA product code for 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation is DWJ.

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 54 devices →

Related Devices (Code: DWJ)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.