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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K993813
Device Name LUMAGEM SCINTILLATION CAMERA
Applicant
Gamma Medica
19355 Business Center Dr.
Suite 8
Northridge,  CA  91324
Applicant Contact BRADLEY E PATT
Correspondent
Gamma Medica
19355 Business Center Dr.
Suite 8
Northridge,  CA  91324
Correspondent Contact BRADLEY E PATT
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/10/1999
Decision Date 01/18/2000
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
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