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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngoscope, Rigid
510(k) Number K063477
Device Name NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
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 Number868.5540
Classification Product Code
CCW  
Date Received11/16/2006
Decision Date 02/09/2007
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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