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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K930284
Device Name METRICIDE
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 Number880.6885
Classification Product Code
MED  
Date Received01/19/1993
Decision Date 12/06/1994
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
Recalls CDRH Recalls
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