Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted— 510(k) K181957

Name: FDA 510(k) clearance K181957
Creator: U.S. Food and Drug Administration
Published: 2019-07-09

Substantially Equivalent

Tianchang Jiarui Packaging Material Co., Ltd.

FDA 510(k) clearance K181957 for Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted, Substantially Equivalent on 2019-07-09. Applicant: Tianchang Jiarui Packaging Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Tianchang Jiarui Packaging Material Co., Ltd.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2018-07-23
Decision date: 2019-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianchang, CN

Download summary PDF View on FDA.gov ↗

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K162258 — Self Sealing Sterilization Pouches2017-04-28

Adverse events under product code FRG

product code FRG

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.