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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K963841
Device Name EZTEST
Applicant
Sgm Biotech, Inc.
10 Evergreen Dr., Suite E
Bozeman,  MT  59715
Applicant Contact JOHN R GILLIS
Correspondent
Sgm Biotech, Inc.
10 Evergreen Dr., Suite E
Bozeman,  MT  59715
Correspondent Contact JOHN R GILLIS
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/25/1996
Decision Date 02/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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