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510(k) K910503

DISCOGRAPHY KIT by B. Braun of America, Inc. — Product Code IZG

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 7, 1991
Date Received
February 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Photofluorographic
Device Class
Class II
Regulation Number
892.1730
Review Panel
RA
Submission Type

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