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510(k) K862415

TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM by Parexel Intl. Corp. — Product Code IWZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1986
Date Received
June 25, 1986
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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