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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 K842903
Device Name SEP PROGRAMMER FOR PUCK U & UD FILMCHANG
Applicant
Elema-Schonander, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Elema-Schonander, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1870
Classification Product Code
IZP  
Date Received07/24/1984
Decision Date 08/21/1984
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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