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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K002951
Device Name MAGELLAN VENTILATOR
Applicant
Oceanic Medical Products, Inc.
8005 Shannon Industrialpark Ln
Atchison,  KS  66002
Applicant Contact WILLIAM M GATES
Correspondent
Oceanic Medical Products, Inc.
8005 Shannon Industrialpark Ln
Atchison,  KS  66002
Correspondent Contact WILLIAM M GATES
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/21/2000
Decision Date 12/08/2000
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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