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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stethoscope, esophageal, with electrical conductors
510(k) Number K062020
Device Name LIFESOUND ESOPHAGEAL STETHOSCOPE
Applicant
NOVAMED, LLC
3460 POINTE CREEK CT. #102
BONITA SPRINGS,  FL  34134 -2015
Applicant Contact PAUL DRYDEN
Correspondent
NOVAMED, LLC
3460 POINTE CREEK CT. #102
BONITA SPRINGS,  FL  34134 -2015
Correspondent Contact PAUL DRYDEN
Regulation Number868.1920
Classification Product Code
BZT  
Date Received07/17/2006
Decision Date 09/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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