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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K073702
Device Name PHONERIS INNER CANNULAE WITH PHONERIS AERO-FLEX VENTILATOR CIRCUIT CONNECTOR
Applicant
LAZARUS MEDICAL LLC
2129 BENEVENTUM CT
RALEIGH,  NC  27606
Applicant Contact CYNTHIA J.M NOLTE
Correspondent
LAZARUS MEDICAL LLC
2129 BENEVENTUM CT
RALEIGH,  NC  27606
Correspondent Contact CYNTHIA J.M NOLTE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received12/31/2007
Decision Date 06/26/2008
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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