HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES— 510(k) K900339

Name: FDA 510(k) clearance K900339
Creator: U.S. Food and Drug Administration
Published: 1990-03-28

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K900339 for HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES, Substantially Equivalent on 1990-03-28. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTS
Device class: Class 2
Regulation: 21 CFR 870.4420
Advisory panel: Cardiovascular
Date received: 1990-01-23
Decision date: 1990-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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