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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 K990246
Device Name STERI-PAK LF BOWIE-DICK TEST PACK
Applicant
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Applicant Contact LON BRUSO
Correspondent
STERITEC PRODUCTS MFG. CO., INC.
680 ATCHISON WAY
SUITE 600
CASTLE ROCK,  CO  80104
Correspondent Contact LON BRUSO
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/26/1999
Decision Date 06/10/1999
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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