ULTRACARE NEUTRALIZING TABLETS— 510(k) K984383

Substantially Equivalent

Allergan, Inc.

FDA 510(k) clearance K984383 for ULTRACARE NEUTRALIZING TABLETS, Substantially Equivalent on 1998-12-18. Applicant: Allergan, Inc..

Clearance details

Applicant: Allergan, Inc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 1998-12-08
Decision date: 1998-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

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.