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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 K952244
Device Name CROSS-CHECKS EO GAS STERILIZATION MONITOR
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
JOJ  
Date Received05/12/1995
Decision Date 08/05/1996
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
Predetermined Change
Control Plan Authorized		 No
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