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FDA 510(k)

OSMONICS SOLUTION DELIVERY SYSTEM

K-Number: K023011 · 2003-06-26

ApplicantOsmonics Medical Systems
Decision Date2003-06-26
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OSMONICS SOLUTION DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osmonics Medical Systems. It received FDA 510(k) clearance on 2003-06-26 under 510(k) number K023011. The device is classified under product code FIN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMONICS SOLUTION DELIVERY SYSTEM?

OSMONICS SOLUTION DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-26. The listed applicant is Osmonics Medical Systems. The 510(k) number is K023011.

When did OSMONICS SOLUTION DELIVERY SYSTEM receive FDA 510(k) clearance?

OSMONICS SOLUTION DELIVERY SYSTEM received FDA 510(k) clearance on 2003-06-26, under 510(k) number K023011.

Who is the listed applicant for OSMONICS SOLUTION DELIVERY SYSTEM?

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

What is the FDA product code for OSMONICS SOLUTION DELIVERY SYSTEM?

The FDA product code for OSMONICS SOLUTION DELIVERY SYSTEM is FIN.

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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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