THERA-FLOW GRADIENT SEQUENTIAL PUMP— 510(k) K943392

Name: FDA 510(k) clearance K943392
Creator: U.S. Food and Drug Administration
Published: 1994-12-30

Substantially Equivalent

Meds Systems, Inc.

FDA 510(k) clearance K943392 for THERA-FLOW GRADIENT SEQUENTIAL PUMP, Substantially Equivalent on 1994-12-30. Applicant: Meds Systems, Inc.. Device class: 2.

Clearance details

Applicant: Meds Systems, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1994-07-14
Decision date: 1994-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, MD, US

Download summary PDF View on FDA.gov ↗

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