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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Disinfectant, Medical Devices
510(k) Number K951983
Device Name IMNI-II
Applicant
Cottrell, Ltd.
7399 S. Tucson Way
Englewood,  CO  80112
Applicant Contact JACK SCOVILLE
Correspondent
Cottrell, Ltd.
7399 S. Tucson Way
Englewood,  CO  80112
Correspondent Contact JACK SCOVILLE
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received04/27/1995
Decision Date 06/20/1995
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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