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FDA 510(k)

THIN FILM DRESSING FOR ULTRASOUND EXAM

K-Number: K011284 · 2001-06-20

ApplicantMartin E. Wendelken
Decision Date2001-06-20
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THIN FILM DRESSING FOR ULTRASOUND EXAM is the device name listed in this FDA 510(k) record. The listed applicant is Martin E. Wendelken. It received FDA 510(k) clearance on 2001-06-20 under 510(k) number K011284. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THIN FILM DRESSING FOR ULTRASOUND EXAM?

THIN FILM DRESSING FOR ULTRASOUND EXAM is a medical device that received FDA 510(k) clearance on 2001-06-20. The listed applicant is Martin E. Wendelken. The 510(k) number is K011284.

When did THIN FILM DRESSING FOR ULTRASOUND EXAM receive FDA 510(k) clearance?

THIN FILM DRESSING FOR ULTRASOUND EXAM received FDA 510(k) clearance on 2001-06-20, under 510(k) number K011284.

Who is the listed applicant for THIN FILM DRESSING FOR ULTRASOUND EXAM?

The FDA 510(k) record lists Martin E. Wendelken as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THIN FILM DRESSING FOR ULTRASOUND EXAM?

The FDA product code for THIN FILM DRESSING FOR ULTRASOUND EXAM is ITX.

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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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