CARDIOPLEGIA ADMINISTRATION SYSTEM CAS— 510(k) K800135

Name: FDA 510(k) clearance K800135
Creator: U.S. Food and Drug Administration
Published: 1980-02-01

Substantially Equivalent

Bentley Laboratories, Inc.

FDA 510(k) clearance K800135 for CARDIOPLEGIA ADMINISTRATION SYSTEM CAS, Substantially Equivalent on 1980-02-01. Applicant: Bentley Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bentley Laboratories, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1980-01-21
Decision date: 1980-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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