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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Environmental Control, Powered
510(k) Number K901028
Device Name ENVIRONMENTAL CONTROL UNIT MODEL 7000
Applicant
Baylor Biomedical Services
3707 Gaston Ave., #216
Dallas,  TX  75246
Applicant Contact JEFF BUTLER
Correspondent
Baylor Biomedical Services
3707 Gaston Ave., #216
Dallas,  TX  75246
Correspondent Contact JEFF BUTLER
Regulation Number890.3725
Classification Product Code
IQA  
Date Received03/06/1990
Decision Date 03/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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