AGACHAMBER SPACER— 510(k) K101348

Substantially Equivalent

Aga Plastic Ind. Com. Ltda.

FDA 510(k) clearance K101348 for AGACHAMBER SPACER, Substantially Equivalent on 2011-04-29. Applicant: Aga Plastic Ind. Com. Ltda..

Clearance details

Applicant: Aga Plastic Ind. Com. Ltda.
Product code: Code NVP
Advisory panel: Anesthesiology
Date received: 2010-05-13
Decision date: 2011-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code NVP

product code NVP

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.