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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, emergency airway
510(k) Number K130405
Device Name RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
Applicant
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact LORI PFOHL
Correspondent
TELEFLEX MEDICAL
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact LORI PFOHL
Regulation Number868.5090
Classification Product Code
BWC  
Date Received02/19/2013
Decision Date 11/06/2013
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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