CRONEX LO-DOSE MAMMOGRAPHY— 510(k) K832504

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K832504 for CRONEX LO-DOSE MAMMOGRAPHY, Substantially Equivalent on 1983-09-12. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.

Clearance details

Applicant
E.I. Dupont DE Nemours & Co., Inc.
Product code
Code IWZ
Device class
Class 1
Regulation
21 CFR 892.1840
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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