COAXIAL BALLOON URETHRAL DILATOR— 510(k) K833690

Name: FDA 510(k) clearance K833690
Creator: U.S. Food and Drug Administration
Published: 1983-11-29

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K833690 for COAXIAL BALLOON URETHRAL DILATOR, Substantially Equivalent on 1983-11-29. Applicant: American Edwards Laboratories. Device class: 3.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code FAA
Device class: Class 3
Advisory panel: Unknown
Date received: 1983-10-18
Decision date: 1983-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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