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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 K250172
Device Name Green Card Bowie-Dick Test (BD115)
Applicant
Steritec Products, Inc. (A Getinge Company)
74 Inverness Dr. E.
Engelwood,  CO  80112
Applicant Contact Chris Muha
Correspondent
Getinge
75 Barbour Pond
Wayne,  NJ  07470
Correspondent Contact Barb Smith
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/21/2025
Decision Date 02/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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