AXSYM GENTAMICIN— 510(k) K935376

Substantially Equivalent

Abbott Mfg., Inc.

FDA 510(k) clearance K935376 for AXSYM GENTAMICIN, Substantially Equivalent on 1994-06-21. Applicant: Abbott Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Abbott Mfg., Inc.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1993-11-08
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.