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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K921275
Device Name SONY LASER VIDEODISC RECORDING SYSTEM
Applicant
Sony Medical Systems
Cynthia A. Sinclair
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Sony Medical Systems
Cynthia A. Sinclair
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number892.2010
Classification Product Code
LMB  
Date Received03/20/1992
Decision Date 06/10/1992
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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