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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837304
Device Name MODELS 246 AND 210F LINEAR ARRAY ULTRASOUND SCANNER
Applicant
Aloka Co., Ltd.
6-22-1, Mure, Mitaka-Shi
Tokyo,  JP 181
Correspondent
Aloka Co., Ltd.
6-22-1, Mure, Mitaka-Shi
Tokyo,  JP 181
Date Received03/18/1983
Decision Date 05/09/1983
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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