Decision Date1991-07-24
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE 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 1991-07-24 under 510(k) number K912208. 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 SAFE-CONNECT CAPD MANUAL ASSIST DEVICE?
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Fresenius USA, Inc.. The 510(k) number is K912208.
When did FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE receive FDA 510(k) clearance?
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912208.
Who is the listed applicant for FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE?
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 FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE?
The FDA product code for FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE is KDJ.
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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.