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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 K910417
Device Name EVIDENCE BIOLOGICAL INDICATOR
Applicant
Skyland Scientific Services, Inc.
2311 S. 7th.Ave.
Bozeman,  MT  59715
Applicant Contact REBECCA W MAHURIN
Correspondent
Skyland Scientific Services, Inc.
2311 S. 7th.Ave.
Bozeman,  MT  59715
Correspondent Contact REBECCA W MAHURIN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received01/30/1991
Decision Date 03/08/1991
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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