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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name indicator, physical/chemical sterilization process
510(k) Number K001444
Device Name STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
Applicant
STERITEC PRODUCTS, INC.
599 TOPEKA WAY, SUITE 700
CASTLE ROCK,  CO  80104
Applicant Contact LINDA NELSON
Correspondent
STERITEC PRODUCTS, INC.
599 TOPEKA WAY, SUITE 700
CASTLE ROCK,  CO  80104
Correspondent Contact LINDA NELSON
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/08/2000
Decision Date 05/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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