3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM— 510(k) K994148

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K994148 for 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM, Substantially Equivalent on 2000-02-01. Applicant: Implant Innovations, Inc..

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 1999-12-08
Decision date: 2000-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code JQC

product code JQC

Other: 1
Total: 1

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.