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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 K854817
Device Name INSTAPURE
Applicant
Teledyne, Inc.
1730 E. Prospect St.
Fort Collins,  CO  80525
Applicant Contact DONALD W RUEHMANN
Correspondent
Teledyne, Inc.
1730 E. Prospect St.
Fort Collins,  CO  80525
Correspondent Contact DONALD W RUEHMANN
Regulation Number880.5045
Classification Product Code
FRF  
Date Received12/03/1985
Decision Date 02/28/1986
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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