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FDA 510(k)

SAFE-T-FACE DISPOSABLE FACE SHIELD

K-Number: K892451 · 1989-05-15

ApplicantBarry S. Smith Co.
Decision Date1989-05-15
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFE-T-FACE DISPOSABLE FACE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Barry S. Smith Co.. It received FDA 510(k) clearance on 1989-05-15 under 510(k) number K892451. 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 SAFE-T-FACE DISPOSABLE FACE SHIELD?

SAFE-T-FACE DISPOSABLE FACE SHIELD is a medical device that received FDA 510(k) clearance on 1989-05-15. The listed applicant is Barry S. Smith Co.. The 510(k) number is K892451.

When did SAFE-T-FACE DISPOSABLE FACE SHIELD receive FDA 510(k) clearance?

SAFE-T-FACE DISPOSABLE FACE SHIELD received FDA 510(k) clearance on 1989-05-15, under 510(k) number K892451.

Who is the listed applicant for SAFE-T-FACE DISPOSABLE FACE SHIELD?

The FDA 510(k) record lists Barry S. Smith Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-T-FACE DISPOSABLE FACE SHIELD?

The FDA product code for SAFE-T-FACE DISPOSABLE FACE SHIELD is FXX.

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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.

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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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