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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 K811071
Device Name VENOUS OXYGEN PROBE
Applicant
G.D. SEARLE AND CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
G.D. SEARLE AND CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1200
Classification Product Code
CCE  
Date Received04/20/1981
Decision Date 05/05/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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