MOP CATHETER— 510(k) K891239

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K891239 for MOP CATHETER, Substantially Equivalent on 1989-11-28. Applicant: Bivona Medical Technologies. Device class: 2.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-07
Decision date: 1989-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bivona Medical Technologies

K952700 — SUPERSLICK1995-10-31
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K935053 — BIVONA NASAL TURBINATE STENT1994-07-01
K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE1993-10-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.