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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 K953905
Device Name IMPERIUM
Applicant
Teledyne Brown Engineering
Cummings Research Park
300 Sparkman Dr.
Huntsville,  AL  35807
Applicant Contact D. K MARTIN
Correspondent
Teledyne Brown Engineering
Cummings Research Park
300 Sparkman Dr.
Huntsville,  AL  35807
Correspondent Contact D. K MARTIN
Regulation Number890.3725
Classification Product Code
IQA  
Date Received08/18/1995
Decision Date 11/21/1995
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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