UROSURGE ACUTRAINER— 510(k) K962770

Name: FDA 510(k) clearance K962770
Creator: U.S. Food and Drug Administration
Published: 1996-08-01

Substantially Equivalent

Princeton Regulatory Assoc.

FDA 510(k) clearance K962770 for UROSURGE ACUTRAINER, Substantially Equivalent on 1996-08-01. Applicant: Princeton Regulatory Assoc.. Device class: 2.

Clearance details

Applicant: Princeton Regulatory Assoc.
Product code: Code KPN
Device class: Class 2
Regulation: 21 CFR 876.2040
Advisory panel: Gastroenterology, Urology
Date received: 1996-07-16
Decision date: 1996-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

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