MONOCRYSTANT PH/LES CATHETER, MODIFICATION— 510(k) K914793

Name: FDA 510(k) clearance K914793
Creator: U.S. Food and Drug Administration
Published: 1993-12-13

Substantially Equivalent

Synectics-Dantec

FDA 510(k) clearance K914793 for MONOCRYSTANT PH/LES CATHETER, MODIFICATION, Substantially Equivalent on 1993-12-13. Applicant: Synectics-Dantec. Device class: 2.

Clearance details

Applicant: Synectics-Dantec
Product code: Code KLA
Device class: Class 2
Regulation: 21 CFR 876.1725
Advisory panel: Gastroenterology, Urology
Date received: 1991-08-26
Decision date: 1993-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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