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510(k) K832504

CRONEX LO-DOSE MAMMOGRAPHY by E.I. Dupont DE Nemours & Co., Inc. — Product Code IWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

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