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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 K053063
Device Name PRO-FLOW MULTIPURPOSE CANNULA
Applicant
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
PRO-TECH SERVICES, INC.
4338 HARBOUR POINTE BLVD. S.W.
MUKILTEO,  WA  98275
Correspondent Contact NEIL SHELLER
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/01/2005
Decision Date 12/13/2005
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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