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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nasal, Oxygen
510(k) Number K830984
Device Name OXYGEN CATHETERS
Applicant
MEDOVATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDOVATIONS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5350
Classification Product Code
BZB  
Date Received03/29/1983
Decision Date 05/18/1983
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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