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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Sterilization
510(k) Number K951113
Device Name CROSS-CHECKS
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
LRT  
Date Received03/10/1995
Decision Date 08/19/1996
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
Recalls CDRH Recalls
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