TAB PAK— 510(k) K882731

Name: FDA 510(k) clearance K882731
Creator: U.S. Food and Drug Administration
Published: 1988-12-14

Substantially Equivalent

Dynex Trading Co.

FDA 510(k) clearance K882731 for TAB PAK, Substantially Equivalent on 1988-12-14. Applicant: Dynex Trading Co.. Device class: 1.

Clearance details

Applicant: Dynex Trading Co.
Product code: Code NXB
Device class: Class 1
Regulation: 21 CFR 890.5050
Advisory panel: Physical Medicine
Date received: 1988-07-01
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

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K885055 — INSU COOL1989-04-26

Adverse events under product code NXB

product code NXB

Death: 3
Other: 1
Total: 4

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.