NEWCHILL(TM) CARDIAC INSULATOR— 510(k) K892804

Name: FDA 510(k) clearance K892804
Creator: U.S. Food and Drug Administration
Published: 1989-07-14

Substantially Equivalent

Acacia Laboratories, Inc.

FDA 510(k) clearance K892804 for NEWCHILL(TM) CARDIAC INSULATOR, Substantially Equivalent on 1989-07-14. Applicant: Acacia Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Acacia Laboratories, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1989-04-17
Decision date: 1989-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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