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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 K900892
Device Name MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE
Applicant
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Applicant Contact DENNIS HENKELMAN
Correspondent
Siemens Gammasonics, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Correspondent Contact DENNIS HENKELMAN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received02/27/1990
Decision Date 05/02/1990
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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