KRYPTON MASKS & TUBING— 510(k) K811118

Name: FDA 510(k) clearance K811118
Creator: U.S. Food and Drug Administration
Published: 1981-06-02

Substantially Equivalent

Medi-Physics Inc. Dba Nycomed Amersham Imaging

FDA 510(k) clearance K811118 for KRYPTON MASKS & TUBING, Substantially Equivalent on 1981-06-02. Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging. Device class: 2.

Clearance details

Applicant: Medi-Physics Inc. Dba Nycomed Amersham Imaging
Product code: Code IYT
Device class: Class 2
Regulation: 21 CFR 892.1390
Advisory panel: Radiology
Date received: 1981-04-24
Decision date: 1981-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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