Decision Date1991-01-11
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius USA, Inc.. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K904806. 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 CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR?
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K904806.
When did CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR receive FDA 510(k) clearance?
CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR received FDA 510(k) clearance on 1991-01-11, under 510(k) number K904806.
Who is the listed applicant for CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR?
The FDA 510(k) record lists Fresenius USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR?
The FDA product code for CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR is KDJ.
Related Clinical Trials
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Other records listing Fresenius USA, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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Related Devices (Code: KDJ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.