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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Liquid-Oxygen, Portable
510(k) Number K882328
Device Name HI FLOW 50
Applicant
Minnesota Valley Engineering, Inc.
407 Seventh St. NW
P.O. Box 234
New Prague,  MN  56071
Applicant Contact SCHOENBAUER
Correspondent
Minnesota Valley Engineering, Inc.
407 Seventh St. NW
P.O. Box 234
New Prague,  MN  56071
Correspondent Contact SCHOENBAUER
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received06/06/1988
Decision Date 06/28/1988
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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