AXSYM OPIATES— 510(k) K951287

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K951287 for AXSYM OPIATES, Substantially Equivalent on 1995-05-18. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1995-03-21
Decision date: 1995-05-18
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.