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FDA 510(k)

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004

K-Number: K974454 · 1997-12-18

ApplicantTucson Medical Corp.
Decision Date1997-12-18
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 is the device name listed in this FDA 510(k) record. The listed applicant is Tucson Medical Corp.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K974454. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004?

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Tucson Medical Corp.. The 510(k) number is K974454.

When did CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 receive FDA 510(k) clearance?

CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 received FDA 510(k) clearance on 1997-12-18, under 510(k) number K974454.

Who is the listed applicant for CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004?

The FDA 510(k) record lists Tucson Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004?

The FDA product code for CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 is OCT.

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Official Source

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