NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS— 510(k) K892856

Name: FDA 510(k) clearance K892856
Creator: U.S. Food and Drug Administration
Published: 1989-11-08

Substantially Equivalent

Acacia Laboratories, Inc.

FDA 510(k) clearance K892856 for NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS, Substantially Equivalent on 1989-11-08. Applicant: Acacia Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Acacia Laboratories, Inc.
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1989-04-18
Decision date: 1989-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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