Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape

Indicator, Physical/chemical Sterilization Process

Intertape Polymer Inc.

The following data is part of a premarket notification filed by Intertape Polymer Inc. with the FDA for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape.

Pre-market Notification Details

Device IDK191741
510k NumberK191741
Device Name:Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant Intertape Polymer Inc. 100 Paramount Dr Suite 300 Sarasota,  FL  34232
ContactMichael Bryant
CorrespondentGary J. Socola
Highpower Validation Testing & Lab Service's Inc. 125 Highpower Road Rochester,  NY  14623
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-01
Decision Date2019-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10304040115470 K191741 000
D6620711869310 K191741 000
H834STDSTEAM1 K191741 000
50732224004124 K191741 000
50732224004131 K191741 000
50732224004148 K191741 000
50732224004155 K191741 000
50732224004162 K191741 000
00889813027790 K191741 000
00889813027806 K191741 000
00889813027813 K191741 000
10304040115456 K191741 000
10304040115463 K191741 000
D6620711869150 K191741 000

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