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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837443
Device Name OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY
Applicant
Medical Diagnostic Instruments, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent
Medical Diagnostic Instruments, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Date Received04/29/1983
Decision Date 06/10/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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