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FDA 510(k)

PROVOCATIVE SENSITIVITY BALLOON

K-Number: K901125 · 1991-01-25

ApplicantWilson-Cook Medical, Inc.
Decision Date1991-01-25
Product CodeKLA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROVOCATIVE SENSITIVITY BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K901125. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVOCATIVE SENSITIVITY BALLOON?

PROVOCATIVE SENSITIVITY BALLOON is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K901125.

When did PROVOCATIVE SENSITIVITY BALLOON receive FDA 510(k) clearance?

PROVOCATIVE SENSITIVITY BALLOON received FDA 510(k) clearance on 1991-01-25, under 510(k) number K901125.

Who is the listed applicant for PROVOCATIVE SENSITIVITY BALLOON?

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

What is the FDA product code for PROVOCATIVE SENSITIVITY BALLOON?

The FDA product code for PROVOCATIVE SENSITIVITY BALLOON is KLA.

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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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