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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 K903504
Device Name HALA'TUS 1 OXYGENATOR
Applicant
The Henry G. Dietz Co., Inc.
14-26 28th Ave.
Long Island City,  NY  11102
Applicant Contact HENRY G DIETZ
Correspondent
The Henry G. Dietz Co., Inc.
14-26 28th Ave.
Long Island City,  NY  11102
Correspondent Contact HENRY G DIETZ
Regulation Number868.5905
Classification Product Code
NFB  
Date Received08/03/1990
Decision Date 01/28/1991
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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