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FDA 510(k)

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER

K-Number: K874296 · 1988-01-07

ApplicantUlti-Med Intl., Inc.
Decision Date1988-01-07
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1988-01-07 under 510(k) number K874296. 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 INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER?

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER is a medical device that received FDA 510(k) clearance on 1988-01-07. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K874296.

When did INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER receive FDA 510(k) clearance?

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER received FDA 510(k) clearance on 1988-01-07, under 510(k) number K874296.

Who is the listed applicant for INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER?

The FDA 510(k) record lists Ulti-Med Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER?

The FDA product code for INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER is FXX.

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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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