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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 K902664
Device Name HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1
Applicant
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Applicant Contact STEVEN CRISAFULLI
Correspondent
Prentke Romich Co.
1022 Heyl Rd.
Wooster,  OH  44691
Correspondent Contact STEVEN CRISAFULLI
Regulation Number890.3725
Classification Product Code
IQA  
Date Received06/18/1990
Decision Date 07/25/1990
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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