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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 K950553
Device Name COLDCIDE-2
Applicant
Metrex Research Corp.
P.O. Box 646
10270 S. Progress Way
Parker,  CO  80134
Applicant Contact VERA BUFFALOE
Correspondent
Metrex Research Corp.
P.O. Box 646
10270 S. Progress Way
Parker,  CO  80134
Correspondent Contact VERA BUFFALOE
Regulation Number880.6890
Classification Product Code
LRJ  
Date Received02/07/1995
Decision Date 03/22/1995
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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