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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K110487
Device Name FLEXIBLE CARDIAC COIL
Applicant
Lbds Holding Company
6440 Sky Pointe Dr.
Suite 140
Las Vegas,  NV  89131
Applicant Contact RICHARD BRYANT
Correspondent
Lbds Holding Company
6440 Sky Pointe Dr.
Suite 140
Las Vegas,  NV  89131
Correspondent Contact RICHARD BRYANT
Regulation Number892.1000
Classification Product Code
MOS  
Date Received02/22/2011
Decision Date 04/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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