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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 K121378
Device Name AIRTRAQ SP AIRTRAQ AVANT
Original Applicant
PRODOL MEDITEC LTD.
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number868.5540
Classification Product Code
CCW  
Date Received05/08/2012
Decision Date 06/21/2012
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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