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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K051988
Device Name OXY-SERVE II OXYGEN CONSERVING REGULATOR
Applicant
Superior Products, Inc.
3786 Ridge Rd.
Cleveland,  OH  44144
Applicant Contact RONALD JOHNSTON
Correspondent
Superior Products, Inc.
3786 Ridge Rd.
Cleveland,  OH  44144
Correspondent Contact RONALD JOHNSTON
Regulation Number868.5905
Classification Product Code
NFB  
Date Received07/22/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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