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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Photofluorographic
510(k) Number K910503
Device Name DISCOGRAPHY KIT
Applicant
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Applicant Contact PEGGY KEIFFER
Correspondent
B. Braun of America, Inc.
824 Twelfth Ave.
P.O. Box 4027
Bethlehem,  PA  18018
Correspondent Contact PEGGY KEIFFER
Regulation Number892.1730
Classification Product Code
IZG  
Date Received02/05/1991
Decision Date 10/07/1991
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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