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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Changer, Film/Cassette, Radiographic
510(k) Number K840389
Device Name SEP PROGRAMMER SEP-M/SINGLE-PLANE &
Applicant
Elema-Schonander, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Elema-Schonander, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1870
Classification Product Code
IZP  
Date Received01/30/1984
Decision Date 02/21/1984
Decision Substantially Equivalent (SESE)
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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