SILICONE PUNCTAL PLUG— 510(k) K980437

Substantially Equivalent

Oasis Medical, Inc.

FDA 510(k) clearance K980437 for SILICONE PUNCTAL PLUG, Substantially Equivalent on 1998-04-30. Applicant: Oasis Medical, Inc..

Clearance details

Applicant: Oasis Medical, Inc.
Product code: Code LZU
Advisory panel: Unknown
Date received: 1998-02-04
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

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Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

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.