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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Scanning, Nuclear
510(k) Number K912286
Device Name CARDIAC SPECT PALLET
Applicant
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Applicant Contact IRENA M KRUTULIS
Correspondent
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195 -7372
Correspondent Contact IRENA M KRUTULIS
Regulation Number892.1350
Classification Product Code
IYZ  
Date Received05/23/1991
Decision Date 08/02/1991
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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