PROTEC-TOP, STERIDENT, BENTO— 510(k) K031022

Name: FDA 510(k) clearance K031022
Creator: U.S. Food and Drug Administration
Published: 2003-04-14

Substantially Equivalent

Ronpak, Inc.

FDA 510(k) clearance K031022 for PROTEC-TOP, STERIDENT, BENTO, Substantially Equivalent on 2003-04-14. Applicant: Ronpak, Inc.. Device class: 2.

Clearance details

Applicant: Ronpak, Inc.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2003-03-31
Decision date: 2003-04-14
Decision: Substantially Equivalent
Clearance type: Special
Location: South Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

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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.