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FDA 510(k)

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

K-Number: K191741 · 2019-08-02

ApplicantIntertape Polymer, Inc.
Decision Date2019-08-02
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is the device name listed in this FDA 510(k) record. The listed applicant is Intertape Polymer, Inc.. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K191741. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Intertape Polymer, Inc.. The 510(k) number is K191741.

When did Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape receive FDA 510(k) clearance?

Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape received FDA 510(k) clearance on 2019-08-02, under 510(k) number K191741.

Who is the listed applicant for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

The FDA 510(k) record lists Intertape Polymer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape?

The FDA product code for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape is JOJ.

Related Devices (Code: JOJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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