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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K090366
Device Name SPEC MODEL M-31
Applicant
Source Production & Equipment Co., Inc.
113 Teal St.
Saint Rose,  LA  70087
Applicant Contact JOHN J MUNRO
Correspondent
Source Production & Equipment Co., Inc.
113 Teal St.
Saint Rose,  LA  70087
Correspondent Contact JOHN J MUNRO
Regulation Number892.5730
Classification Product Code
KXK  
Date Received02/13/2009
Decision Date 04/22/2009
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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