PHARMASEAL EYE PREP TRAY— 510(k) K850119

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K850119 for PHARMASEAL EYE PREP TRAY, Substantially Equivalent on 1985-05-09. Applicant: American Pharmaseal Div. Ahsc.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code HNR
Advisory panel: Ophthalmic
Date received: 1985-01-14
Decision date: 1985-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.