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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K080527
Device Name TWINGUARD WITH CAPNOGRAPH ACCESSORY
Applicant
TRAWAX PTY LIMITED
29662 AVANTE
LAGUNA NIGUEL,  CA  92677
Applicant Contact CINDY MARTIN
Correspondent
TRAWAX PTY LIMITED
29662 AVANTE
LAGUNA NIGUEL,  CA  92677
Correspondent Contact CINDY MARTIN
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
MNK  
Date Received02/26/2008
Decision Date 10/31/2008
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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