STANDARD FOLEY SYSTEM PAK— 510(k) K951443

Name: FDA 510(k) clearance K951443
Creator: U.S. Food and Drug Administration
Published: 1995-06-15

Substantially Equivalent

Trinity Laboratories, Inc.

FDA 510(k) clearance K951443 for STANDARD FOLEY SYSTEM PAK, Substantially Equivalent on 1995-06-15. Applicant: Trinity Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Trinity Laboratories, Inc.
Product code: Code FCN
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1995-03-29
Decision date: 1995-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salisbury, MD, US

Download summary PDF View on FDA.gov ↗

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