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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837329
Device Name SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
Applicant
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Correspondent
Carolina Medical Electronics
P. O. Box 307
King,  NC  27021
Date Received03/08/1983
Decision Date 06/07/1983
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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