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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Non-Rebreathing
510(k) Number K883766
Device Name MOUTH-TO-MASK VENTILATORY ADJUNCT
Applicant
MEDIC ONE
9400 E. 17TH
INDEPENDENCE,  MO  64052
Applicant Contact DAN WHITE
Correspondent
MEDIC ONE
9400 E. 17TH
INDEPENDENCE,  MO  64052
Correspondent Contact DAN WHITE
Regulation Number868.5570
Classification Product Code
KGB  
Date Received09/06/1988
Decision Date 10/21/1988
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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