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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 K895668
Device Name DIGICAM LHP (VIDEO INTERFACE OPTION)
Applicant
SIEMENS GAMMASONICS, INC.
2501 N. BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Applicant Contact W HENKELMAN
Correspondent
SIEMENS GAMMASONICS, INC.
2501 N. BARRINGTON RD.
HOFFMAN ESTATES,  IL  60195 -7372
Correspondent Contact W HENKELMAN
Regulation Number892.2040
Classification Product Code
LMC  
Date Received09/20/1989
Decision Date 11/15/1989
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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