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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 K260181
Device Name LF Process Indicator Tape for Steam Sterilization
Applicant
Intertape Polymer Group
100 Paramount Dr.
Suite 300
Sarasota,  FL  34232
Applicant Contact Michael Johnson
Correspondent
FLX Consulting
3192 Wheeler Station Rd.
Bloomfield,  NY  14469
Correspondent Contact Mike Nolan
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received01/21/2026
Decision Date 02/20/2026
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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