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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 K991841
Device Name HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Applicant Contact DAN LAOR
Correspondent
GE MEDICAL SYSTEMS F.I. HAIFA
P.O. BOX 170
TIRAT HACARMEL,  IL 30200
Correspondent Contact DAN LAOR
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/28/1999
Decision Date 08/26/1999
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
Recalls CDRH Recalls
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