FDA 510(k)

FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD

K-Number: K934974 · 1994-04-13

Decision Date1994-04-13

Product CodeFXX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Mid America Medical, Inc.. It received FDA 510(k) clearance on 1994-04-13 under 510(k) number K934974. 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 FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD?

FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD is a medical device that received FDA 510(k) clearance on 1994-04-13. The listed applicant is Mid America Medical, Inc.. The 510(k) number is K934974.

When did FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD receive FDA 510(k) clearance?

FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD received FDA 510(k) clearance on 1994-04-13, under 510(k) number K934974.

Who is the listed applicant for FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD?

The FDA 510(k) record lists Mid America Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD?

The FDA product code for FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD is FXX.

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Related Devices (Code: FXX)

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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.