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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 K011427
Device Name MBI PD-103 SL; MBI PD-103 SH
Applicant
Mills Biopharmaceuticals, Inc.
120 NE 26th St.
Oklahoma City,  OK  73105
Applicant Contact STANLEY MILLS
Correspondent
Mills Biopharmaceuticals, Inc.
120 NE 26th St.
Oklahoma City,  OK  73105
Correspondent Contact STANLEY MILLS
Regulation Number892.5730
Classification Product Code
KXK  
Date Received05/08/2001
Decision Date 08/31/2001
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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