MODEL 1859 TUMI/PRESSURE MODULE— 510(k) K873695

Name: FDA 510(k) clearance K873695
Creator: U.S. Food and Drug Administration
Published: 1988-01-27

Substantially Equivalent

Life-Tech Intl., Inc.

FDA 510(k) clearance K873695 for MODEL 1859 TUMI/PRESSURE MODULE, Substantially Equivalent on 1988-01-27. Applicant: Life-Tech Intl., Inc.. Device class: 2.

Clearance details

Applicant: Life-Tech Intl., Inc.
Product code: Code EXY
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1987-09-14
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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