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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 K981497
Device Name STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
Applicant
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Applicant Contact TOM ROLL
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Correspondent Contact TOM ROLL
Regulation Number880.2800
Classification Product Code
FRC  
Date Received04/27/1998
Decision Date 10/29/1998
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
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