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FDA 510(k) Application Details - K121378
Device Classification Name
Laryngoscope, Rigid
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
868.5540
More FDA Info for this Regulation Number
Classification Product Code
CCW
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More FDA Info for this Product Code
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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