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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828619
Device Name OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M
Applicant
Ohmic , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ohmic , Ltd.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received11/23/1982
Decision Date 01/03/1983
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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