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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K883324
Device Name DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
Applicant
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Applicant Contact MARRIBETH ADAMS
Correspondent
Siemens Gammasonics, Inc.
2000 Nuclear Dr.
Des Plaines,  IL  60018
Correspondent Contact MARRIBETH ADAMS
Regulation Number892.2040
Classification Product Code
LMC  
Date Received08/05/1988
Decision Date 02/27/1989
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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