FDA 510(k)

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

Numéro K : K191741 · 2019-08-02

Date de décision2019-08-02

Code produitJOJ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : JOJ)

K2619923M™ Attest™ Intégrateur de Chlore et Vapeur (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group K251991SafeSecure 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™ bandelettes de test PASerim Research K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

Source officielle

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