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FDA 510(k)

REPROCESSED BALOON INFLATION DEVICE

K-Number: K053188 · 2006-05-04

ApplicantSterilmed, Inc.
Decision Date2006-05-04
Product CodeNKU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED BALOON INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sterilmed, Inc.. It received FDA 510(k) clearance on 2006-05-04 under 510(k) number K053188. The device is classified under product code NKU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED BALOON INFLATION DEVICE?

REPROCESSED BALOON INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 2006-05-04. The listed applicant is Sterilmed, Inc.. The 510(k) number is K053188.

When did REPROCESSED BALOON INFLATION DEVICE receive FDA 510(k) clearance?

REPROCESSED BALOON INFLATION DEVICE received FDA 510(k) clearance on 2006-05-04, under 510(k) number K053188.

Who is the listed applicant for REPROCESSED BALOON INFLATION DEVICE?

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

What is the FDA product code for REPROCESSED BALOON INFLATION DEVICE?

The FDA product code for REPROCESSED BALOON INFLATION DEVICE is NKU.

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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.

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