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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 K892639
Device Name THE ORIGINAL PULSE-PAK
Applicant
Jones Sales Co.
4109 Ravine Dr.
Canal Winchester,  OH  43110
Applicant Contact RUSSELL, SR.
Correspondent
Jones Sales Co.
4109 Ravine Dr.
Canal Winchester,  OH  43110
Correspondent Contact RUSSELL, SR.
Regulation Number868.5905
Classification Product Code
NFB  
Date Received04/12/1989
Decision Date 10/05/1989
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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