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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K822301
Device Name ROYAL 1 OXYGEN CONCENTRATOR
Applicant
Proto-Med, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Proto-Med, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/03/1982
Decision Date 08/19/1982
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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