DISSECTOR, TROUTMAN CORNEAL— 510(k) K760186

Substantially Equivalent

V. Mueller O.V. Baxter Healthcare Corp.

FDA 510(k) clearance K760186 for DISSECTOR, TROUTMAN CORNEAL, Substantially Equivalent on 1976-08-04. Applicant: V. Mueller O.V. Baxter Healthcare Corp.. Device class: 1.

Clearance details

Applicant
V. Mueller O.V. Baxter Healthcare Corp.
Product code
Code HNN
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HNN

product code HNN
Injury
183
Malfunction
4,106
Total
4,289

Source: openFDA MAUDE database, through . 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.