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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K991565
Device Name TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S
Applicant
Smv America
8380 Darrow Rd.
Twinsburg,  OH  44087
Applicant Contact PHIL VERNON
Correspondent
Smv America
8380 Darrow Rd.
Twinsburg,  OH  44087
Correspondent Contact PHIL VERNON
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/05/1999
Decision Date 08/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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