FDA 510(k)

TRI-BALL

K-Number: K994074 · 2000-06-08

Decision Date2000-06-08

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

TRI-BALL is the device name listed in this FDA 510(k) record. The listed applicant is Leventon, S.A.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K994074. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-BALL?

TRI-BALL is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Leventon, S.A.. The 510(k) number is K994074.

When did TRI-BALL receive FDA 510(k) clearance?

TRI-BALL received FDA 510(k) clearance on 2000-06-08, under 510(k) number K994074.

Who is the listed applicant for TRI-BALL?

The FDA 510(k) record lists Leventon, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-BALL?

The FDA product code for TRI-BALL is BWF.

Other records listing Leventon, S.A. 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.

K053149SPIRO-BALL K040752DOSI-FUSER K952810DOSI-FLOW, MODELS 20 & 30 K851058DOSI FLOW

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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.