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.

Clearance details

Applicant: Surgitek
Product code: Code FAP
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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