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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, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K910453
Device Name TOPS NEEDLE TIP PROBE & PVC TIP PROBE
Applicant
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Applicant Contact NANCY E SHADFORTH
Correspondent
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Correspondent Contact NANCY E SHADFORTH
Regulation Number868.1200
Classification Product Code
CCE  
Date Received02/01/1991
Decision Date 08/13/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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