FDA 510(k) Application Details - K121378

Device Classification Name Laryngoscope, Rigid

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510(K) Number K121378
Device Name Laryngoscope, Rigid
Applicant PRODOL MEDITEC LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 868.5540

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Classification Product Code CCW
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Date Received 05/08/2012
Decision Date 06/21/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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