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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 K780850
Device Name SEARLE NEONATAL OXYGEN PROBE
Applicant
WILL ROSS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
WILL ROSS CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1200
Classification Product Code
CCE  
Date Received05/22/1978
Decision Date 08/23/1978
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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