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FDA 510(k)

3M SURGICAL MASK WITH FACE SHEILD

K-Number: K940707 · 1994-05-23

Applicant3M Company
Decision Date1994-05-23
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3M SURGICAL MASK WITH FACE SHEILD is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1994-05-23 under 510(k) number K940707. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M SURGICAL MASK WITH FACE SHEILD?

3M SURGICAL MASK WITH FACE SHEILD is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is 3M Company. The 510(k) number is K940707.

When did 3M SURGICAL MASK WITH FACE SHEILD receive FDA 510(k) clearance?

3M SURGICAL MASK WITH FACE SHEILD received FDA 510(k) clearance on 1994-05-23, under 510(k) number K940707.

Who is the listed applicant for 3M SURGICAL MASK WITH FACE SHEILD?

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 SURGICAL MASK WITH FACE SHEILD?

The FDA product code for 3M SURGICAL MASK WITH FACE SHEILD is FXX.

Related Clinical Trials

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.

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: FXX)

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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