FDA 510(k)

FRESENIUS STERILE STAY SAFE CAP

K-Number: K083542 · 2008-12-29

ApplicantFresenius Medical Care North America

Decision Date2008-12-29

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FRESENIUS STERILE STAY SAFE CAP is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2008-12-29 under 510(k) number K083542. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS STERILE STAY SAFE CAP?

FRESENIUS STERILE STAY SAFE CAP is a medical device that received FDA 510(k) clearance on 2008-12-29. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K083542.

When did FRESENIUS STERILE STAY SAFE CAP receive FDA 510(k) clearance?

FRESENIUS STERILE STAY SAFE CAP received FDA 510(k) clearance on 2008-12-29, under 510(k) number K083542.

Who is the listed applicant for FRESENIUS STERILE STAY SAFE CAP?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRESENIUS STERILE STAY SAFE CAP?

The FDA product code for FRESENIUS STERILE STAY SAFE CAP is KDJ.

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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.