LUMEN-4 URODYNAMIC CATHETER— 510(k) K833628

Substantially Equivalent

Surgitek

FDA 510(k) clearance K833628 for LUMEN-4 URODYNAMIC CATHETER, Substantially Equivalent on 1983-11-28. Applicant: Surgitek. Device class: 2.

Clearance details

Applicant: Surgitek
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1983-10-14
Decision date: 1983-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Surgitek

K946296 — QUADRA-COIL URETERAL STENT1995-03-06
K944391 — OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM1995-02-07
K943491 — RIGHT ANGLE UROLOGIC LASER FIBER1994-08-05
K941952 — SURGITEK INFUSER1994-05-24
K933260 — HELICAL STONE/FLATWIRE STONE BASKETS1994-01-11

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