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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K872359
Device Name ENVIRACAIRE MODEL EV-1
Applicant
Enviracaire Corp.
747 Bowman Ave.
Hagerstown,  MD  21740
Applicant Contact GEORGE B DAVIS
Correspondent
Enviracaire Corp.
747 Bowman Ave.
Hagerstown,  MD  21740
Correspondent Contact GEORGE B DAVIS
Regulation Number880.5045
Classification Product Code
FRF  
Date Received06/18/1987
Decision Date 12/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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