CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH— 510(k) K854113

Name: FDA 510(k) clearance K854113
Creator: U.S. Food and Drug Administration
Published: 1986-01-08

Substantially Equivalent

American Bentley

FDA 510(k) clearance K854113 for CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH, Substantially Equivalent on 1986-01-08. Applicant: American Bentley. Device class: 1.

Clearance details

Applicant: American Bentley
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1985-10-08
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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