Decision Date1978-05-12
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
FOME-CUF PVC is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1978-05-12 under 510(k) number K780583. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FOME-CUF PVC?
FOME-CUF PVC is a medical device that received FDA 510(k) clearance on 1978-05-12. The listed applicant is Bivona Medical Technologies. The 510(k) number is K780583.
When did FOME-CUF PVC receive FDA 510(k) clearance?
FOME-CUF PVC received FDA 510(k) clearance on 1978-05-12, under 510(k) number K780583.
Who is the listed applicant for FOME-CUF PVC?
The FDA 510(k) record lists Bivona Medical Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FOME-CUF PVC?
The FDA product code for FOME-CUF PVC is BTR.
Other records listing Bivona Medical Technologies 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: BTR)
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.