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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 K832793
Device Name NEOCATH 1000 W/HEPCOTE
Applicant
ORANGE MEDICAL INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ORANGE MEDICAL INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.1200
Classification Product Code
CCE  
Date Received08/19/1983
Decision Date 09/26/1983
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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