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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Changer, Radiographic Film/Cassette
510(k) Number K792068
Device Name MEMCO 300 FILM CHANGER
Applicant
Memco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Memco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1860
Classification Product Code
KPX  
Date Received10/15/1979
Decision Date 11/16/1979
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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