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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 K191741
Device Name Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
Applicant
Intertape Polymer, Inc.
100 Paramount Dr.
Suite 300
Sarasota,  FL  34232
Applicant Contact Michael Bryant
Correspondent
Highpower Validation Testing & Lab Service'S, Inc.
125 Highpower Rd.
Rochester,  NY  14623
Correspondent Contact Gary J. Socola
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received07/01/2019
Decision Date 08/02/2019
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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