PMS AMNIOCENTESIS TRAY/KIT— 510(k) K850632

Name: FDA 510(k) clearance K850632
Creator: U.S. Food and Drug Administration
Published: 1985-05-22

Substantially Equivalent

Professional Medical Services

FDA 510(k) clearance K850632 for PMS AMNIOCENTESIS TRAY/KIT, Substantially Equivalent on 1985-05-22. Applicant: Professional Medical Services. Device class: 1.

Clearance details

Applicant: Professional Medical Services
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1985-02-19
Decision date: 1985-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Salt Lake, UT, US

Download summary PDF View on FDA.gov ↗

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