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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 K930683
Device Name EZTEST-GAS
Applicant
Sgm Biomedical, Inc.
10 Evergreen Dr., Suite E
Bozeman,  MT  59715
Applicant Contact JOHN R GILLIS
Correspondent
Sgm Biomedical, Inc.
10 Evergreen Dr., Suite E
Bozeman,  MT  59715
Correspondent Contact JOHN R GILLIS
Regulation Number880.2800
Classification Product Code
FRC  
Date Received02/10/1993
Decision Date 03/04/1997
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
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