AUSTIN ENTERIC SYSTEM— 510(k) K860194

Name: FDA 510(k) clearance K860194
Creator: U.S. Food and Drug Administration
Published: 1986-02-20

Substantially Equivalent

Austin Biological Laboratories

FDA 510(k) clearance K860194 for AUSTIN ENTERIC SYSTEM, Substantially Equivalent on 1986-02-20. Applicant: Austin Biological Laboratories. Device class: 1.

Clearance details

Applicant: Austin Biological Laboratories
Product code: Code JSE
Device class: Class 1
Regulation: 21 CFR 866.2320
Advisory panel: Microbiology
Date received: 1986-01-22
Decision date: 1986-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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