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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 Pt.e Blvd. SW
Mukilteo,  WA  98275
Applicant Contact NEIL SHELLER
Correspondent
Pro-Tech Services, Inc.
4338 Harbour Pt.e Blvd. SW
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
Predetermined Change
Control Plan Authorized		 No
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