PVC ABDOMINAL/RECTAL PRESSURE CATHETER— 510(k) K954315

Name: FDA 510(k) clearance K954315
Creator: U.S. Food and Drug Administration
Published: 1995-11-30

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K954315 for PVC ABDOMINAL/RECTAL PRESSURE CATHETER, Substantially Equivalent on 1995-11-30. Applicant: Life-Tech Intl., Inc.. Device class: 2.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1995-09-15
Decision date: 1995-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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