GENTAMICIN KIT(FPIA)— 510(k) K852013

Name: FDA 510(k) clearance K852013
Creator: U.S. Food and Drug Administration
Published: 1985-06-10

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K852013 for GENTAMICIN KIT(FPIA), Substantially Equivalent on 1985-06-10. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1985-05-09
Decision date: 1985-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

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