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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomographic, Nuclear
510(k) Number K904599
Device Name D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
Applicant
Digital Design, Inc.
3060 E. Business Park Dr.
Norcross,  GA  30071
Applicant Contact THOMAS BERGQUIST
Correspondent
Digital Design, Inc.
3060 E. Business Park Dr.
Norcross,  GA  30071
Correspondent Contact THOMAS BERGQUIST
Regulation Number892.1310
Classification Product Code
JWM  
Date Received10/10/1990
Decision Date 04/23/1991
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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