ATS DOBELL & O'CONNOR'S IODINE— 510(k) K890861

Name: FDA 510(k) clearance K890861
Creator: U.S. Food and Drug Administration
Published: 1989-03-23

Substantially Equivalent

Alpha-Tec Systems, Inc.

FDA 510(k) clearance K890861 for ATS DOBELL & O'CONNOR'S IODINE, Substantially Equivalent on 1989-03-23. Applicant: Alpha-Tec Systems, Inc.. Device class: 1.

Clearance details

Applicant: Alpha-Tec Systems, Inc.
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1989-02-21
Decision date: 1989-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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