Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape— 510(k) K191741

Name: FDA 510(k) clearance K191741
Creator: U.S. Food and Drug Administration
Published: 2019-08-02

Substantially Equivalent

Intertape Polymer, Inc.

FDA 510(k) clearance K191741 for Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape, Substantially Equivalent on 2019-08-02. Applicant: Intertape Polymer, Inc.. Device class: 2.

Clearance details

Applicant: Intertape Polymer, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2019-07-01
Decision date: 2019-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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