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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K123176
Device Name ISO-GARD CLEARAIR MASK
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Applicant Contact Angela Bouse
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
P.O. Box 12600
Research Triangle Park,  NC  27709
Correspondent Contact Angela Bouse
Regulation Number868.5430
Classification Product Code
CBN  
Date Received10/10/2012
Decision Date 02/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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