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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 K912796
Device Name SPORE STRIP
Applicant
Raven Biological Laboratories, Inc.
P.O. Box 6408
5017 Leavenworth St.
Omaha,  NE  68106
Applicant Contact FRED KERNS
Correspondent
Raven Biological Laboratories, Inc.
P.O. Box 6408
5017 Leavenworth St.
Omaha,  NE  68106
Correspondent Contact FRED KERNS
Regulation Number880.2800
Classification Product Code
FRC  
Date Received06/25/1991
Decision Date 04/02/1992
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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